Events during September 2023

The principles of validation and verification have long been established and laboratories are generally familiar with these although there remain some issues which are commonly seen within verification reports during assessments. Some of these require some further attention and discussion, including consideration of sample type, verification across multiple sites and approaches used when upgrading analysers. Alongside these common issues, ISO 15189:2022 has now been issued with assessments to become mandatory to the new standard from January 2024 and whilst the principles of validation and verification are generally unchanged, there are some differences which will require review of internal procedures and approaches to verification. Awareness of these changes will form a part of the presentation, along with issues commonly seen, being hoped these will promote some thought as to how laboratories can consider the local approaches used.

"Don’t worry, you’ll be next" – have you ever said, or heard this phrase when it comes to training opportunities?

Should you have a queue? Should you make promises? Or do you risk losing staff if you don’t?

This session will discuss considerations to ensure fairness in training opportunities, from an individual and organisational perspective. It will also look at how to ensure your opportunities and training are inclusive, and support diversity.

Expanding your role into Point-of-Care Testing – a career opportunity to consider

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.

Delegates attending this session will learn about and gain knowledge on the introduction and application of the new EQA scheme to cover digital pathology in Cellular Pathology.

Authentic learning experiences and simulations are an established approach to healthcare education known to prepare students for the world of work. A recent study showed that 93% of employers believed that biomedical science graduates failed to meet employability requirements due to lack of practical and technical skills (Hussain and Hicks, 2022). Whilst placements can bridge these gaps, opportunities are limited and unpaid, restricting accessibility. Organising careers events and collaboration with The School of Health and Society, external employers, the Careers and Enterprise team and key stakeholders has enhanced the curriculum content to meet the needs of employers.

Development of the mentorship group, Biomedical Science Careers Support at the University of Salford has enabled successful career development for students. Collaborating with The School of Health and Society, the implementation of an interprofessional education event will be embedded into the curriculum. A recent project involving the introduction of Pathology specimen reception and blood transfusion simulations, allowed students to practice workplace skills, while enabling aspects of the profession to be taught that would otherwise have been impossible to teach. Introducing scenarios coupled with authentic workplace dilemmas including health and safety, quality, and problem solving, not only helps satisfy degree accreditation, but facilitating reflection also feeds into a requirement for HCPC registration and continuous professional development. Related to this, the Biomedical Science mentorship group has also introduced the trial of a ‘portfolio club’. Here students were supported by the teams IBMS portfolio verifier to begin collecting evidence towards their IBMS Registration Training Portfolio.

The impact of these activities has already been demonstrated, for instance 100% success rate with placement applications for those students who engaged in this extracurricular club. Data collected from surveys from participants and feedback from employers forms an evidence base to demonstrate the success of authentic learning experiences and improving employability. The added value of academics from professional backgrounds and cross University collaboration can be expanded to encompass further areas of biomedical science and healthcare careers, with progression to include patient contact and pre-placement professionalism training. These authentic learning experiences and simulations can be sustainably integrated into various areas of the curriculum to bridge the skills gap and improve employment opportunities to all graduates.

A role with a difference – anatomical pathology technologist in a mortuary

The Higher Specialist Diploma (HSD) is the main route for gaining Fellowship (FIBMS) status. In this session I will provide a brief overview of the IBMS Higher Specialist Diploma (HSD) qualification explaining the disciplines that the HSD can be undertaken in, who the qualification is aimed at and how the qualification is assessed.

I will then provide advice and guidance on the completion of the portfolio element of the qualification and explain what a good portfolio looks like. I will also briefly explain how to prepare for the exam element of the qualification. There will also be an opportunity to ask questions about the HSD.

EQA: What’s happening?

The idea of generating blood cells in vitro for transfusion is not new but only now we are reaching the point where the concept is reaching clinical trials. In vitro derived blood cells (namely platelets and red cells at this stage) are complementary to blood donor-derived products but with distinct advantages: biological safety, more resilient supply line and potentially less immunogenicity.

We have developed a forward programming approach relying on the overexpression of transcription factors in pluripotent stem cells to produce the platelet mother cells, the megakaryocytes, conferring added efficiency and purity to the culture system. The challenges that remain to be addressed are related to transition to GMP production, optimising platelet release in the culture and quality control of the final product. The power of genome editing has also allowed us to explore the production of platelets with added clinical benefit (immune silent, added thrombotic potential).

Red cell production from primary CD34+ progenitors has been demonstrated in academic laboratories about a decade ago. We are now mid-way through a first in human study to look at the potential of using in vitro derived red cells for transfusion. One of the main benefits would be a potentially longer survival of the manufactured red cells in the circulation than their donor-derived counterpart. This would allow spacing out transfusion intervals for patients on chronic transfusion programme, thereby reducing iron overload.