Policy responses and statements

Name of organisation:
Department of Health
Name of policy document:
Laboratory guidelines for the diagnosis of mycobacterium tuberculosis infection - A paper for consultation
Deadline for response:
15 September 2006

Background: A set of Laboratory Guidelines for the diagnosis of Mycobacterium tuberculosis infection is being developed for use in the NHS laboratories in England and Wales by the Department of Health Monitoring and Laboratory Guidelines Working Group. Stakeholders for the laboratory guidelines are invited to comment on the provisional guidelines recommendations.

During this consultation period, stakeholders may want to:

- Comment on the key recommendations by the guideline developers
- Comment on the improvement the proposed guidelines would bring to the laboratory elements of the diagnosis, management and prevention of TB, when used with the relevant components of NICE Guidance on TB and the recently revised National SOP, BPSOP 40
- Comment on costs implications and how it may benefit the service to implement these guidelines
- Make final comments on the guidelines prior to publication


COMMENTS ON
DH TB Monitoring and Laboratory Services Working Group
Chair: Dr. Grace Smith
 Draft Laboratory Guidelines for the Diagnosis of Mycobacterium tuberculosis Infection
17 July – 31 August 2006

Page number

Item Number

Comments –
Royal College of Physicians of Edinburgh

4

Introduction

The Royal College of Physicians of Edinburgh welcomes the proposals set out in these guidelines as broadly appropriate for good clinical care and control of tuberculosis. The guidelines represent workable best practice that should already be in place in many routine NHS laboratories.

If they can be achieved nation wide, they will bring about an improvement in care and may in some cases result in reduced length of hospital stay. Once the standards are agreed it will be helpful for clinicians to be made aware of what they can expect from laboratories in this field.

5

Para 3

1. Many laboratories will struggle to offer a 6 day service. It may be more reasonable, therefore, to specify that at least a 5-day service should be available. Out-of-hours smear testing may compromise quality, largely related to the way in which the specimen is processed.

2. Obviously the microscopy result should be released as soon as the investigation has been completed; however, as mentioned above, this may not always be possible within one working day in a small laboratory. It is important to distinguish between “acute” specimens (that do require urgent auramine staining, out of hours if necessary) and routine or follow-up specimens.

5-6

Para 4

1. For smaller laboratories processing fewer specimens the financial outlay involved in introducing a liquid culture system may be unrealistic, meaning that specimens for mycobacterial investigations will need to be transferred to a nearby facility with the relevant technology and accreditation.

2. If liquid cultures are employed there is probably no reason why conventional solid cultures should be set up as it has been established that liquid cultures are quite adequate on their own.

3. Although a positive culture should be obtained within 21 days, it is common practice to incubate specimens for up to 6 weeks before declaring them culture negative.

6

Para 4 (b)

Some laboratories may choose to do their own in-house geneprobe assays for preliminary identification of Mycobacterial cultures, although definitive identification should still rest with the appropriate Reference Laboratory.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324    ext 608
Fax: 0131 220 3939

[28 September 2006]

 

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