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1. Purpose of Guidance

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

• Ensure that the assessment and accreditation process is applied fairly to all applicant laboratories
• Enable CPA officers to assess whether an Immunology Assessor is required
• Enable applicant laboratories to understand when direction by a Consultant Immunologist (see section 3.1 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 Immunology examinations carried out by applicant laboratories

2. Scope of Immunology for the purposes of this Guidance

2.1 CPA will expect sessional input from a Consultant Immunologist and will send one or more Immunology Assessors when the repertoire includes some or all of the following examinations, regardless of volume:

• Autoantibody screening with reporting of positive results, patterns and titres
• All complement examinations, apart from C3 and C4
• All cellular immunology examinations
• All specific IgE and functional allergy examinations
• All other autoantibodies [including ds-DNA, ENA, ANCA, endomysial and tTG, organ specific autoantibodies; paraneoplastic and glycolipid antibodies], with the exception of those specifically identified below (section 2.3)

2.2 Laboratories carrying out these examinations must apply for assessment in Immunology.  CPA places no restrictions on the repertoire of immunological testing carried out by a laboratory with sessional consultant immunologist input, except in so far as it is incumbent on the laboratory to justify the quality of the service provided where tests are only carried out infrequently.   Where reporting is carried out by BMS staff, there must be evidence of specific training and competence, and reporting rules must be agreed with the visiting consultant immunologist [G5.1, G5.3].

2.3 The following examinations do not require specific input from a consultant immunologist and CPA will not send an Immunology Assessor

• Rheumatoid factor
• Autoantibody screening with reporting of negative results; positives sent away for confirmation and titration
• Serum immunoglobulins, serum and urine electrophoresis
• Total IgE
• C3 and C4
• Anticardiolipin antibodies
• Thyroid microsomal/peroxidase antibodies
• Intrinsic factor antibodies

3. Consultant input to meet Standard B1

3.1 A consultant immunologist is defined as a clinical pathologist or healthcare scientist who has evidence of training and experience in immunology as normally exemplified in the United Kingdom by completion of the MRCPath examination in Immunology and eligibility for inclusion on the specialist register for Immunology, if medically qualified.  For healthcare scientists without MRCPath, competency will be defined on the basis of knowledge and skills appropriate to the post and equivalent to the MRCPath.

3.2 Standard B1.2 identifies the requirements for the provision of cover for disciplines where there is no on-site consultant.  Particular attention is drawn to the requirement for a normal requirement of one weekly on-site visit [B1.2b], the ready availability of interpretative advice [G5.1] and awareness of the users of the availability of consultant advice [G5.3].   Remote electronic authorisation and review of results are specifically encouraged, although these are not standards.  Remote reporting cannot substitute for the requirement for one weekly on site visit [B1.2b], but may supplement such a visit.  The CPA PAC accepts that, in the interests of efficiency, it may be appropriate for the weekly session to be flexibly worked as one day/fortnight.

3.3 CPA will expect the contractual arrangements covering the provision of the consultant immunologist input to be clear and in writing [B1.2a], and assessors will ask to review this documentation.  This may be in the form of a service level agreement or as part of the consultant’s job plan.   The following aspects should be included:

Professional direction is required to ensure that:

• appropriate equipment is selected and commissioned [D1.2]
• an appropriate users’ handbook is available [E1.2]
• an appropriate examination repertoire is selected [F1.1]
• procedures are reviewed [F2.1]
• reporting is carried out effectively [G2]
• clinical advice is available [G5]
• appropriate clinical audit is undertaken (H1)

The visiting Consultant Immunologist will:

• undertake review of EQA performance [H5]
• participate in the quality improvement system [H6]
• participate in the Laboratory Management system [A1.5]
• be responsible for supervision of immunology-specific training [B9]

3.4 Where a laboratory carrying out immunology testing, as defined in section 2.1, has only a single immunologist, CPA’s guidance note on single-handed practice will apply.