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1          Purpose of Guidance

Guidance on the scope and direction of Andrology 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 Andrology assessor is required

Enable applicant laboratories to understand what level of professional direction will be required to satisfy CPA standard B1

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

Enable PAC members and CPA officers to make consistent decisions in relation to Andrology examinations carried out in applicant laboratories.

2          Background 

Clinical and diagnostic Andrology services may be provided as part of a stand-alone Andrology laboratory, as part of an Assisted Conception Unit (ACU) or as part of the repertoire of any other pathology discipline. The Human Fertilisation & Embryology Authority (HFEA) is responsible for the issuing of licences to those laboratories offering certain assisted reproduction techniques. In the terms of the Human Fertilisation & Embryology Act (1990) the licence is issued to the ‘Person Responsible’. Many of these laboratories are part of clinical units and the ‘Person Responsible’ may be a clinician. The majority of semen analyses are carried out in pathology laboratories whose main focus of activity could be any of the other disciplines. These laboratories may offer a limited range of tests.

3          Definitions

In the absence of any available formal qualifications in Andrology the following groups of people are acceptable to give professional direction to the service.

Person Responsible is the person to whom HFEA issues a licence. The range of activity covered by the licence is clearly stated on the licence. This person may be a clinician usually a consultant Gynaecologist.

Consultant Pathologist or Clinical Scientist specialising in reproductive medicine

Consultant Pathologist In another discipline with an interest in Andrology

4          Andrology laboratories and assisted conception units

Provide a comprehensive range of Andrology testing and facilities for cryopreservation of spermatozoa and shall hold a licence to provide these services granted by Human Fertilisation & Embryology Authority (HFEA). Either a consultant pathologist or a clinical scientist of equivalent status who specialises in reproductive medicine and/or andrology shall professionally direct these laboratories.

5          Andrology sections in other pathology disciplines

Provide a limited range of tests.  These laboratories may be directed by a consultant of another pathology discipline with an interest in Andrology.

6          Andrology testing that may be undertaken in the absence of a consultant specialising in reproductive medicine.

Sperm concentration
Sperm motility
Sperm morphology
Post vasectomy semen specimens
Seminal fructose
Sperm antibodies
Post coital test
Sperm viability

7          The following tests shall be referred to a centre holding an HFEA licence

CPA will provide general laboratory assessment but does not accredit the following procedures.

Cryopreservation and thawing gametes

Artificial insemination (partner) (AI)

Donor insemination (DI)

In vitro fertilisation (IVF)

Intra-cytoplasmic sperm injection (ICSI)

Research on gametes or embryos

Any other tests or techniques that may be added to licensing requirements in the future 

8          CPA assessment requirements

Those laboratories whose sole repertoire is reproductive medicine will require a specialist assessor.