Events in 2023

The session will provide an overview of the Histopathology Reporting qualifications outlining the success so far and then will focus on the new limited scope Reporting qualification for those involved in Cervical Screening. It will provide guidance on the eligibility criteria for this qualification, the portfolio requirements and the support needed by candidates from colleagues in order to undertake the qualification.

A robust approach to Registration Training Portfolio verification is crucial to maintaining the high standards of confidence in the reputation of HCPC-registered biomedical scientists. The transition to a digital-only Registration Training Portfolio using the ePortfolio platform Onefile will provide a more streamlined approach to portfolio verification allowing verifiers to focus on what matters most… the assessment of a trainee’s competence.

This talk (the last of three) will demonstrate how verifiers can use Onefile to verify the evidence provided by the trainee and approved by their training officer or manager, using a number of tools to track evidence against the HCPC Standards of Proficiency. Onefile’s ePortfolio allows verifiers to gain a holistic view of the trainee’s understanding, enabling verifiers to scaffold the discussion during the verification visit and laboratory tour. We will see how Onefile provides a comprehensive system to arrange the verification visit (either virtually or in person), complete the verification report, and manage the final sign-off of the verified portfolio. Onefile’s inbuilt audit trail minimises the administration associated with portfolio verification, and we will show how this can be used to help improve the quality of education and training in the workplace.

We suggest that this talk will be most informative to post-registration staff involved in overseeing training, such as training officers/managers and verifiers.

Additional talks focusing on other elements of Onefile are scheduled for the lunchtime programme on Wednesday (Hall: 11) and the morning subsidiary programme on Thursday (Hall: 4).

The management of low grade smear abnormalities has posed problems for over 30 years and these will be described in some detail leading on to the most recent difficulty caused by the HPV Triage Pathway in the Cervical Screening Programme. The concept of HPV Entrapment Syndrome will be introduced and management strategies to deal with this difficult problem will be discussed. As well as explaining what HPV Entrapment means, there will be a detailed case presentation of a typical patient followed by a review of some of the numerous smear abnormalities that prevented her from leaving the Triage Programme.

A modular approach to the Specialist Portfolios

The IVDR is the new regulatory instrument for placing IVDs on the European market. The aims of the IVDR are to provide a robust, transparent and sustainable IVD framework, harmonize divergence in implementation (as experienced with the IVDD) and most importantly to increase patient safety. The document runs to 156 pages (compared to 43 for the IVDD, containing 114 articles and 15 annexes. The IVDR places more emphasis on the economic operators (actors) involved in the IVD supply chain, from the manufacturer to the customer.

Manufacturers have the obligations to design and manufacture products in compliance with the IVDR; evaluate product performance and manage risk, have a Quality Management System, create and maintain product technical documentation, conduct post market surveillance, and implement field safety corrective actions. One of the biggest changes with IVDR is the introduction of a new rules-based approach for product classification. Under IVDR, Notified Bodies perform conformity assessment on 80% of IVDs (compared to 20% under the IVDD, which becomes stricter as the risk class increases. There are also enhanced concepts for performance evaluation and clinical evidence.

Under the IVDR there is a requirement to state the clinical purpose in the intended use. Thus, in order to comply with the new regulation, manufacturers must revise all intended purpose statements in product labelling. Further, there is the obligation to gather a large amount of data to evaluate both analytical and clinical performance. Manufacturers are required to continually evaluate performance across the whole product lifecycle through post market surveillance and vigilance, with reports for the highest-risk devices uploaded to the new EUDAMED database on an annual basis.

The IBMS's view of ISO 15189:2022

EQA of Autoimmunity

The presentation gives an overview of the NHS Patient Safety Incident Response Framework, it’s principles and requirements. There is also a brief summary of the Systems Engineering Initiative for Patient Safety (SEIPS) and how this is different to previous models of investigation. The presentation then focusses on how PSIRF has been implemented at Northumbria Healthcare, an acute and community provider in the North East of England, with a focus on the phased implementation approach used by the PSIRF leads. The speaker will also cover the challenges in the implementation to date and the successes experienced so far.

EUCAST – striving towards a complete system

Shiga toxin-producing Escherichia coli (STEC) O157:H7 has been the most clinically significant STEC serotype in the UK for over four decades. However, over the last 10 years we have observed a decrease in STEC O157:H7 and an increase in non-O157 STEC serotypes, such as O26:H11. Little is known about the microbiology and epidemiology of non-O157 STEC. This presentation describes the virulence, clinical outcomes and epidemiology of non-O157 STEC, focusing on the most commonly detected serotype, STEC O26:H11.