Applies to UK clinical laboratories only

UK NEQAS ICC & ISH is required by our accrediting body, the United Kingdom Accreditation Service (UKAS), to have in place a formal system whereby the performance of its UK based clinical laboratories is monitored.

We must notify the National Quality Assurance Advisory Panel (NQAAP), which is part of the Royal College of Pathologists of any cases of persistent substandard (poor) performance in participating UK clinical laboratories.

Poor performance monitoring mechanisms operated by UK NEQAS ICC & ISH are constantly under review to ensure they are fair and fit-for-purpose.

They currently consist of the following procedures:

Warning Letter (Amber Rating)

Biomarker modules: two scores of 8/20 or less over the course of 5 assessments runs on the UK NEQAS ICC & ISH material.

The biomarker modules include the breast hormonal IHC, breast HER2 IHC and ISH, gastric HER2 IHC and ALK IHC modules.

Non-biomarker modules: three scores of 8/20 or less over the course of 5 assessments runs on the UK NEQAS ICC & ISH material.

A warning letter is issued to the laboratory concerned. The purpose of the letter is to ensure that the laboratory is aware of the situation. It requests them to contact the Scheme Director to discuss the situation. The Scheme Director will then provide advice and assistance on how the laboratory concerned might improve their results.

Poor performance (Red Rating)

Poor performance is defined as:

• • • three scores of 8/20 or less in a Biomarker module
    • four scores of 8/20 or less in a Non-Biomarker module

In both cases this is over the course of 5 assessment runs and applies to the assessment of UK NEQAS ICC & ISH distributed materials (not in-house control samples).

Triggering of the poor performance criteria will result in a poor performance letter being sent to the clinical lead of thelaboratory concerned. The letter requires the laboartory to contact the Scheme Director to discuss the situation.

At the same time the NQAAP for Cellular Pathology Chair will be made aware of the poor performance issue.

All parties will work together to resolve the situation.

Further details

For full details of the UK NEQAS ICC & ISH Performance Monitoring procedures and criteria please consult the Participant’s Manual, which can be found on our Forms, Certficates and Scope page under the Participants’ tab.

Referral request for technical advice, feedback and opinion

UK NEQAS ICC & ISH is happy to offer an opinion on participants’ staining quality and where required, give advice on how it can be improved.

Use the Feedback and Opinion Form if you wish to submit slides to this service. A copy of the form can be found on our Forms, Certficates and Scope page under the Participants’ tab.

NOTE:

• for any antibodies not currently covered in the scope of UK NEQAS ICC & ISH there may be a charge for this service. If you wish to check our scope please consult our UKAS accreditation documentation, which can be found on our Forms, Certficates and Scope page under the Participants’ tab.

• this service is not to be used if you are dissatisfied with the marks your slides received at an Assessment Run. If this is the case, refer to the information given on the Assessment Procedure page.