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This lecture will provide context and understanding of the processes and practices used within Northumbria Healthcare for ensuring Quality is underpinned throughout the procurement process within Pathology IT. Including:

Governance
Lessons learned from previous projects
Learning from others
Contract Development
Frameworks and Technical Standards

This presentation will give:

Training requirements for Biomedical Scientists and Clinical Scientists
Insight into how the skills of a Biomedical Scientist enabled development toward Consultant Clinical Scientist.

The safety and performance of diagnostic devices used in pathology (equipment, software, reagents etc) is assured through regulation. The UK is developing a new set of regulations that will completely change how the safety and performance of diagnostic devices can be demonstrated. Regulations will have an impact on procurement and availability and will affect how new products can be developed in pathology facilities.

In recent years, healthcare policy has been moving towards the concept of patients being able to receive their pathology test results directly, it is likely that pathology providers may need to consider the communication of some laboratory test results directly to patients.

This is a very different group of people to what pathology providers are used to. Expansion of concepts such as reference intervals and what is significant need to be explored in the context of a more general audience.

Role of MDT – Clinical Perspective; Colposcopy for patients with learning difficulties

Skin

Specialist portfolios: Updated, flexible and achievable

Semen analyses is essential to understand male factor infertility and to allow planning for treatment options. Absence or low numbers of viable sperm become a challenge and to define whether obstruction removal surgery is needed or whether it would be possible to possible to boost sperm numbers if hormonally related problems exist.

Semen diagnostic analyses is used to define which treatment modality, timed sexual intercourse, intrauterine insemination (IUI) or in vitro fertilisation (IVF) or if intracytoplasmic sperm injection (ICSI) is needed. Despite all efforts, around 70% of women remain barren after treatment and little understanding exists especially on male factor which forms almost half the problem. Poor to very poor sperm quality relating to multiple factors such as counts, motility and morphology are increasingly associated with declining embryo quality, pregnancy outcomes and recurrent miscarriage. Asthenozoospermia/asthenospermia) is related to reduced sperm motility, whereas teratozoospermia refers to morphology condition. For the first time the field of diagnostic andrology has a chance to make substantial male factor contribution towards the knowledge of poor success rates and have available a numeral encompassed in `teratozoospermia index’ (TZI). The TZI has a maximum of four defects per abnormal spermatozoon: one each for head, midpiece and principal piece, and one for excess residual cytoplasm. The TZI is the sum of all abnormalities divided by the sum of abnormal spermatozoa, thus always giving a result between 1.00 and 4.00.

Ordinary semen analyses so far have had limited predictive value, but TZI will form a meaningful and constructive contribution to reproductive medicine, allowing for less invasive and less commercially driven and unnecessary expensive ICSI treatments. To derive the TZI numeral does not require significantly more investment other than performing a simple calculation to reach this index numeral, while conforming to WHO standards. There are sufficient parallels between poor sperm quality and DNA damage and recurrent miscarriage for instance, and morphology deficit evidence is beginning to emerge, adding TZI potential substantially to diagnostic andrology analyses as well as in providing clinical steers.

The Teratozoospermia Index (TZI) is a recent addition to WHO guidelines. The interpretation of the guidelines and whether laboratories should/should not undertake this test is contentious and may cause issues for many services.

This debate will involve two speakers: one for and one against TZI implementation. This will give attendees a rounded review of this area and support their decisions in undertaking this examination.

The Teratozoospermia Index (TZI) is a recent addition to WHO guidelines. The interpretation of the guidelines and whether laboratories should/should not undertake this test is contentious and may cause issues for many services. This debate will involve two speakers: one for and one against TZI implementation.

Sperm morphology assessment is part of a basic semen analysis. Accurate assessment of the percentage of normal-shaped sperm can help in diagnosing male factor infertility and in signposting to the most effective assisted conception therapy if needed.

Beyond classifying whether or not a sperm shape is normal, the introduction of the teratozoospermia index (TZI) requires us to now look at each sperm in far more detail. We are asked to assess the percentage of specific abnormalities such as head shape (is it too thin or amorphous?), midpiece (is it slightly asymmetric?) and tail (is it a little too short?). However, such assessments require additional time-consuming work for the biomedical andrologist and is it really of any clinical relevance?

Most sperm shape defects are easy to detect by the basic analysis without this extra work. Examples include globozoospermia, macrocephaly, decapitated sperm syndrome and fibrous sheath dysplasia, all of which are simply diagnosed, as often the vast majority of sperm affected.

The cellular pathology of clots and cell blocks

The human factors in change processes