Andrology and accreditation - An opportunity for Cytologists.
TL;DR: The development (from an existing service) and subsequent United Kingdom Accreditation Service (UKAS) accreditation of andrology testing in a District General Hospital setting is described, describing key areas for development and utilising cytopathology and histopathology staff of various grades and thus providing one avenue of skill redeployment for those cy topathology staff who will no longer provide morphological screening expertise to the CSP.
Abstract: The change to HPV testing as the primary screening modality is under way or imminent in the Cervical Screening Programmes (CSP) of the UK nations. This will necessitate major structural changes in all cytopathology laboratories, both in those that continue to provide a service to the CSP and those that do not. This article describes the development (from an existing service) and subsequent United Kingdom Accreditation Service (UKAS) accreditation of andrology testing in a District General Hospital setting, describing key areas for development and utilising cytopathology and histopathology staff of various grades and thus providing one avenue of skill redeployment for those cytopathology staff who will no longer provide morphological screening expertise to the CSP. This article is protected by copyright. All rights reserved.
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TL;DR: In this article, a narrative review aims to describe standardized laboratory procedures for an accurate assessment of semen parameters that incorporate both quality control (QC) and quality assurance (QA) practices.
Abstract: Semen analysis is a basic test for evaluating male fertility potential, as it plays an essential role in driving the future management and treatment of infertility in couples. Manual semen analysis includes the evaluation of both macroscopic and microscopic parameters, whereas automated semen analysis is conducted through a computer-aided sperm analysis system and can include additional parameters that are not evaluated by manual analysis. Both quality control (QC) and quality assurance (QA) are important to ensure reproducible results for semen analysis, and represent fundamental checks and balances of all stages (pre-analytical, analytical, and post-analytical) of semen analysis. To ensure accuracy and precision, the laboratory technicians' performance should be evaluated biannually. This narrative review aims to describe standardized laboratory procedures for an accurate assessment of semen parameters that incorporate both QC and QA practices.
6 citations
TL;DR: In this paper , a narrative review aims to describe standardized laboratory procedures for an accurate assessment of semen parameters that incorporate both quality control (QC) and quality assurance (QA) practices.
Abstract: Semen analysis is a basic test for evaluating male fertility potential, as it plays an essential role in driving the future management and treatment of infertility in couples. Manual semen analysis includes the evaluation of both macroscopic and microscopic parameters, whereas automated semen analysis is conducted through a computer-aided sperm analysis system and can include additional parameters that are not evaluated by manual analysis. Both quality control (QC) and quality assurance (QA) are important to ensure reproducible results for semen analysis, and represent fundamental checks and balances of all stages (pre-analytical, analytical, and post-analytical) of semen analysis. To ensure accuracy and precision, the laboratory technicians' performance should be evaluated biannually. This narrative review aims to describe standardized laboratory procedures for an accurate assessment of semen parameters that incorporate both QC and QA practices.
6 citations
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01 Dec 2012
TL;DR: The following guidelines have been developed by the ABA to be used in andrology laboratories and should be seen as the discipline specific supplementary to the Clinical Pathology Accreditation (UK) Ltd accreditation ‘Standards for Medical Laboratory’.
Abstract: 1. Personnel and training 157 2. Premises and environment 158 3. Equipment, information systems and materials 159 3.1 General 159 3.2 Equipment 159 3.3 Media and reagents 159 3.4 Semen analysis 159 3.5 Cryopreservation 160 4. Pre-analytical process 161 4.1 Information for users 161 4.2 Request forms 162 4.3 Specimen collection 162 4.4 Specimen reception 162 4.5 Specimen rejection 163 5. Analytical process 163 5.1 Diagnostic semen analysis 163 5.2 Post vasectomy semen analysis 163 The following guidelines have been developed by the ABA to be used in andrology laboratories. They are aimed at providing guidance on current best practice for both diagnostic and treatment-associated andrology and should be seen as the discipline specific supplementary to the Clinical Pathology Accreditation (UK) Ltd (CPA) accreditation ‘Standards for Medical Laboratory’ and the HFEA Code of Practice for licensed fertility centres (HFEA, 2010). All laboratories are obliged to comply with other legislation such as the Health and Safety at Work Act (1974), Control of Substances Hazardous to Health (COSHH) regulations (1999), the Human Fertilisation and Embryology Act 1990 (as amended) and the European Union Tissue and Cells Directives for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (2004/23/EC, 2006/17/EC and 2006/86/EC). The overarching accreditation standards for medical laboratories produced by the CPA (UK) Ltd are presented in the following eight sections: Organisation and Quality Management System; Personnel; Premises and Environment; Equipment, Information Systems and Materials; Pre Examination Process; Examination Process; Post Examination Phase; and Evaluation and Quality Assurance. As such the ABA Guidelines for Good Practice are subdivided along similar lines but with the chief omission of the generic section on quality management. Guidelines for current best practice have been drawn together from current legislation, from the World Health Organisation (2010), experts in the field of clinical and laboratory andrology (and the ABA as their representative professional body) and from professionals from associated disciplines e.g. embryology, blood and tissue banking. Evidence for best practice is provided where relevant and where possible, otherwise a consensus and pragmatic view of the ABA is provided. Human Fertility, 2012; 15(4): 156–173 © 2012 The British Fertitlity Society ISSN 1464-7273 print/ISSN 1742-8149 online DOI: 10.3109/14647273.2012.747888
18 citations
TL;DR: These 2016 guidelines replace the 2002 British Andrology Society laboratory guidelines and should be regarded as definitive for the UK in the provision of a quality PVSA service, accredited to ISO 15189:2012, as overseen by the United Kingdom Accreditation Service (UKAS).
Abstract: Post-vasectomy semen analysis (PVSA) is the procedure used to establish whether sperm are present in the semen following a vasectomy. PVSA is presently carried out by a wide variety of individuals, ranging from doctors and nurses in general practitioner (GP) surgeries to specialist scientists in andrology laboratories, with highly variable results.Key recommendations are that: (1) PVSA should take place a minimum of 12 weeks after surgery and after a minimum of 20 ejaculations. (2) Laboratories should routinely examine samples within 4 h of production if assessing for the presence of sperm. If non-motile sperm are observed, further samples must be examined within 1 h of production. (3) Assessment of a single sample is acceptable to confirm vasectomy success if all recommendations and laboratory methodology are met and no sperm are observed. Clearance can then be given. (4) The level for special clearance should be <100 000/mL non-motile sperm. Special clearance cannot be provided if any motile sperm are observed and should only be given after assessment of two samples in full accordance with the methods contained within these guidelines. Surgeons are responsible both preoperatively and postoperatively for the counselling of patients and their partners regarding complications and the possibility of late recanalisation after clearance. These 2016 guidelines replace the 2002 British Andrology Society (BAS) laboratory guidelines and should be regarded as definitive for the UK in the provision of a quality PVSA service, accredited to ISO 15189:2012, as overseen by the United Kingdom Accreditation Service (UKAS).
15 citations
TL;DR: This guideline intends to help those working within diagnostic andrology to better understand the concept of uncertainty, and how it can be applied to semen analysis and post-vasectomy semen analysis.
Abstract: Uncertainty of measurement has become a paramount factor to consider in pathology. In the UK, consideration of uncertainty of measurement is mandatory for medical laboratories who apply to be accredited against ISO15189:2012 via the United Kingdom Accreditation Service. This guideline intends to help those working within diagnostic andrology to better understand the concept of uncertainty, and how it can be applied to semen analysis and post-vasectomy semen analysis. The various areas where uncertainty may exist are identified, and guidance is provided to minimise this uncertainty. This guidance is produced by the Association of Biomedical Andrologists alongside experts in the field of andrology, in order to aid laboratory scientists in understanding and undertaking important tasks that will improve quality of their service.
8 citations
TL;DR: The present report will summarise key aspects of these publications that are of greatest relevance to laboratory scientists.
Abstract: In 2016, the British Journal of Biomedical Science published 36 reports outlining specific advances in each of the various disciplines within biomedical science. These were one review, 25 original articles, 9 'In Brief' reports and one letter to the Editor. Of these, the majority were in blood science (5 in biochemistry, 7 in haematology and 2 in immunology) and infection science (8 in microbiology, 2 in virology) with a smaller number in cellular sciences (6 in cellular pathology and 2 in cytopathology). Three reports considered both biochemistry and immunology, while another reported an advance in the identification of chromosomal abnormalities. The present report will summarise key aspects of these publications that are of greatest relevance to laboratory scientists.
5 citations