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News from Association of Practising Pathologists , APP

PATHCON & LAB EXPO 2022, an Annual Conference of the Association of Practising Pathologists, was held on the 17th and 18th of December 2022 at Hotel Taj Vivanta in New Delhi, India. Spread over two days, this unique pathology conference was organized in a hybrid mode.

This conference was attended by 623 delegates from all over the country who participated in 12 workshops and presentations by 52 faculty members. The organizing committee conducted all the sessions and workshops on the 17th. Simultaneously young and upcoming pathologists presented 120 oral papers and 132 posters that day, while on the 18th of December, senior pathologists shared their experiences in the form of exciting presentations. The discussion and deliberations covered various pathology topics, including advances in molecular diagnostics, haematology, oncology, and clinical biochemistry. They were valuable and relevant to the association members and delegates, including many postgraduate students.

One highlight of the conference was the keynote address by Dr Neeraj Jain, President of the APP, who spoke about the role of quality in pathology. He emphasized the critical importance of various quality tools for more accurate diagnoses and improving patient outcomes. Another key theme of the conference was the importance of collaboration and interdisciplinary approaches in pathology research and practice. Speakers stressed the need for pathologists to work closely with clinicians, specialists in bio-informatics and other healthcare professionals to ensure that pathology contributes to the delivery of precision medicine. The President announced a new scheme for certification of compliance with standards defined by the association. He also announced the dates of quarterly meetings and the annual Pathcon & Lab Expo 2023.

LAB EXPO 2022, the most sought-after medical laboratory exhibition in this part of India, is an integral part of PATHCON. Almost all industry partners showcase their latest laboratory equipment, devices, and technologies used in the medical field. As a result, attendees can expect to see a range of innovative laboratory tools, such as microscopes, scanners, centrifuges, auto analyzers, and other diagnostic devices. In addition, exhibitors also showcased various software solutions for data management, lab automation, and quality control. Apart from the equipment, the Lab Expo provided an opportunity to attend seminars and workshops presented by industry experts, offering attendees a chance to update their knowledge on recent developments and techniques in the field. Lab Expo also provided an opportunity to exchange knowledge and ideas and create an interface between laboratory medicine professionals and the industry.

Overall, this Pathcon and Lab Expo 2022 was a grand success and provided an excellent opportunity for members of the association and delegates to be updated on the latest trends and advancements in medical laboratory technology.

 

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Accredited medical analysis dedicated to the fight against cancer

An important step forward in the fight against cancer in Italy was taken with the accreditation of the first structures for prevention and treatment of oncological diseases. The medical laboratories of the IRCSS Oncological Reference Center – Department of Research and Advanced Cancer Diagnostics in Aviano (province of Pordenone) and of the University Hospital of Padua UOC Pediatric Oncohematology have been accredited by Accredia, the Italian Accreditation Body, according to the international standard ISO 15189 “Medical laboratories – Requirements for quality and competence”.

This is the first case of accreditation in Italy of two structures entirely dedicated to medical analysis for the prevention, diagnosis, treatment and rehabilitation of oncological diseases. To issue the accreditation, Accredia verified the competence of the laboratories to conduct the tests following the requirements defined in the ISO standard. These checks are repeated periodically to ensure that the requirements are maintained over time.

Accreditation according to ISO 15189 ensures quality laboratory medical care in line with a standard of excellence that brings together the best rules defined at an international level, recognized and adopted throughout the world, for the benefit of both patients and healthcare professionals. Laboratory medicine is of increasingly central importance within the system of prevention, diagnosis, monitoring and guidance of therapies, including oncological ones. It is estimated that today about 80% of clinical decisions are based on tests performed by medical laboratories.

The standard provides for the verification, both in terms of conformity of the management system and of technical adequacy of the laboratory, of all the processes involved in the conduct of the accredited tests, including personnel competence, appropriateness of the tests, sampling and transport of samples, work environment, metrological traceability of results, quality assurance, interpretation of test results by medical staff and communication of the outcome to the patient.

The attestation issued by Accredia flanks, without replacing it, the so-called institutional accreditation of the National Health Service, and is a complementary tool, aimed at improving health services and the efficiency of the medical laboratory, and ensuring that the results of the analyses are reliable, with the aim of protecting public health and offering the community safe and quality healthcare.

In particular, the accreditation of the laboratory of the Oncological Reference Center of Aviano includes tests concerning the therapeutic monitoring of oncolytic drugs, the research into mutations and somatic rearrangements, genetic tests for mutations and germline polymorphisms.

The Pediatric Oncohematology Laboratory of Padua accreditation includes research regarding the main genetic-molecular lesions associated with leukemia, such as NOTCH1 and FBXW7 mutations, the t(8;14) and t(2;5) translocations.  The accreditation also covers the screening for research into Soft Tissue Sarcomas and the mutagenic analysis with the NGS system and Sanger sequencing.

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A2LA’s Ashley Kamauf Selected for ISO/IEC 17020 Revision Working Group

Cybersecurity Program Manager Ashley Kamauf has been selected as one of only two people from the United States to represent the American National Standards Institute (ANSI) for the ISO/IEC 17020 Revisions Working Group

Ashley-Kamauf

ISO/CASCO made the decision to revise ISO/IEC 17020 in December of 2022. Over the past few years, similar standards have been revised, and in order to more closely align with those standards, ISO/IEC 17020 will be revised as well. The updated standard will incorporate revisions determined by the working group, as well as items from the ILAC P15 publication.

A2LA’s Cybersecurity Program Manager Ashley Kamauf has been selected as one of only two people from the United States to represent the American National Standards Institute (ANSI) for the ISO/IEC 17020 Revision Working Group. Kamauf was nominated for the working group by Trace McInturff, A2LA’s Vice President of Accreditation Services and she was selected based on her extensive knowledge of the standard and pain points for organizations in the industry.

“I am very excited to participate in the working group and have the opportunity to impact the trajectory of the standard moving forward,” said Kamauf. “I believe my experience with both training and managing many different types of inspection bodies will be beneficial to the group in achieving our goals.”

ISO/IEC 17020 Working Group meetings will take place in Geneva, Switzerland, and the group will take up to three years to create, finalize, approve, and publish the revised standard.

“A2LA is very pleased that Ashley has been selected by ANSI as one of the United States experts to participate on the newly created ISO/IEC 17020 Working Group,” said Trace McInturff, Vice President, Accreditation Services. “Ashley brings a wealth of inspection expertise to the working group and we are happy to be able to support ISO/CASCO in this very critical activity.”

For more information about A2LA’s ISO/IEC 17020 Inspection Body Program, visit https://a2la.org/accreditation/inspection-body/.

 

Media Contact: Wallis Shamieh; wshamieh@a2la.org; 301-644-3230

 

A2LA is a non-profit, non-governmental, third-party accreditation body, offering internationally recognized accreditation services to testing and calibration laboratories, inspection bodies, biobanking facilities, stand-alone sampling organizations, proficiency testing providers, reference material producers, and product certifiers. For more information, visit https://a2la.org/.

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World Accreditation Day 2023

June 9th 2023 marks World Accreditation Day (#WAD2023), a global initiative established by ILAC and IAF to promote the value of accreditation.

IAF and ILAC celebrate World Accreditation Day (WAD) with our members, partners, stakeholders and users of conformity assessment. The theme for WAD 2023 is:

Accreditation: Supporting the Future of Global Trade

This theme will showcase how accreditation and accredited conformity assessment activities support the ongoing global supply chain restructuring that continues to be a source of trade normalization as organisations seek new markets and investment opportunities to build resilient and flexible supply chains. This is likely to reinforce long-term growth in multilateral and bilateral trade relationships and augment the value of the ILAC/IAF mutual recognition arrangements in promoting greater supply chain efficiency and resilience.

This year’s theme, Accreditation: Supporting the Future of Global Trade also focuses on how accreditation supports the United Nations Sustainable Development Goals (SDGs) 1, 2, 3, 5, 8, 9, 10, 14, and 17.

IAF and ILAC will be releasing a joint statement by the IAF and ILAC Chairs, a brochure and a video along with the already published poster for use in celebrations. In addition, a virtual event will be hosted by IAF and ILAC on 9th June. Case studies and research on benefits that accreditation can provide in support of this theme are available on the Public Sector Assurance and Business Benefits websites.

We encourage everyone to celebrate with us online using the hashtag #WAD2023, to attend our virtual event and to contact your local accreditation body for further details on local media and online seminars and programs they may be organising. A list of IAF Members is available here, and a list of ILAC Members is available here.

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Biobanking-new scheme of accreditation in Kazakhstan

The Republic of Kazakhstan is a young state in Central Asia with a little over 30 years of independent history. Located in the very center of the Eurasian continent, surrounded by major geopolitical players, our country strives to constantly improve its competitiveness, and above all, in the economy and trade. Our state considers accreditation as one of the main tools for achieving success. National Center for Accreditation (NCA) – a state accreditation body under the Ministry of Trade and Integration of Kazakhstan – does not stop at assessing the already traditional for the country, scopes of accreditation, and is constantly introducing new schemes into its work. One of them is biobanking.

 

The term “Biobank” came into use by scientists and entrepreneurs in Kazakhstan not so long ago. The development in Kazakhstan of such promising areas such as plant and livestock breeding, transplantation and transfusion, treatment of genetically determined diseases and many others turned out to be impossible without biobanks – specialized repositories for the organized collection, labeling, processing, storage and analysis of samples of biological materials and related data for scientific and biomedical research.

 

Not every repository of biological materials can be called a biobank. Specially selected collections of plants and animals or their biomaterials, including samples taken from humans, can be used in research and clinical care only under sufficiently stringent conditions for any manipulation with them.

 

The scope of biobanking in Kazakhstan has changed a lot over the past thirty years. It began with small, mostly university repositories that were created for research and specific projects needs. Gradually, institutional and state-supported repositories, commercial biological repositories, population and virtual biobanks have developed.

 

However, a real breakthrough in the history of biobanking began with the development and adoption of the international standard ISO 20387 “Biotechnology — Biobanking — General requirements for biobanking”. The standard was created to build confidence in biobanking. It establishes requirements that allows biobanks to demonstrate high competence in their work and the ability to provide biological material and the related data of an appropriate quality, which in turn, will ensure a high level of research, development or services.

 

Since 2020, the National Center for Accreditation of Kazakhstan has been working actively on the implementation of biobank accreditation schemes. As part of the promotion of the ISO 20387 standard, NCA specialists have held webinars with the involvement of a foreign lecturer for the target audience of scientists, animal breeders and medical workers.  As well as training for biobank staff and seminars for university teachers and students in order to build the capacity of technical experts.

 

The National Center for Accreditation of Kazakhstan has published a video and posts, articles and interviews are regularly released on the official website and social networks on the development of biobanking.

 

NCA specialists have received theoretical and practical training and visited accredited biobanks in countries such as South Korea and India. On the basis of the skills and knowledge acquired, three specialists have been awarded the title of expert bio-banking auditors. NCA’s procedural documents have been amended to ensure that we are ready to accept applications for the initial accreditation of biobanks.

 

Biobanks in Kazakhstan have shown particular interest in the standard. Today, about 2-3 potential applicants in our country are preparing for accreditation. Accreditation is seen as a good motivation for biobank staff. Accreditation will contribute to positioning the biobank as an organization that complies with all the requirements established by the standard for proper record keeping, clinical and diagnostic control, implementation of appropriate management of material resources and personnel, maintaining feedback with consumers, monitoring quality, ensuring the effectiveness of services provided and taking into account the opinions of patients.

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ARAC Recognition to the ILAC MRA continued

As a result of the recent ILAC Arrangement Council ballot, the continuation of the recognition for the Arab Accreditation Cooperation (ARAC) as a recognised regional cooperation body of ILAC has been confirmed. The endorsed AMC recommendation is shown below:

The ILAC AMC recommends that the scope of recognition of the ARAC MLA to the ILAC MRA be:
 

  • continued for the accreditation of calibration and testing laboratories using ISO/IEC 17025, medical testing laboratories using ISO 15189 and inspection bodies using ISO/IEC 17020.
     

It is recommended that the next re-evaluation of ARAC is scheduled to begin no later than September 2024.

Information on the recognised regions including ARAC to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/

We look forward to continuing to work with our colleagues from ARAC.

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SADCA achieves Recognition to the ILAC MRA

As a result of the recent ILAC Arrangement Council ballot, The Southern African Development Community Cooperation in Accreditation (SADCA) has been granted recognition as regional cooperation body of ILAC. The endorsed AMC recommendation is shown below:

The ILAC AMC recommends that recognition of the SADCA MRA to the ILAC MRA be granted: 

  • for the accreditation of calibration and testing laboratories using ISO/IEC 17025. 

It is recommended that the first re-evaluation of SADCA is scheduled to begin no later than August 2025.

Information on the recognised regions now including SADCA to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/

We extend our congratulations to SADCA and look forward to continuing to work with our colleagues from SADCA.

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Signatory status of OGA, Guatemala, suspended

The signatory status of Oficina Guatemalteca de Acreditación (OGA), Guatemala, to the ILAC MRA was suspended on 16 March 2023. This suspension to the ILAC MRA is a result of the suspension of OGA from the IAAC MLA and in accordance with IAF/ILAC A2 Annex 7.

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Signatory Status – KOLAS

The signatory status of Korea Laboratory Accreditation Scheme (KOLAS), Korea, to the ILAC MRA has been extended to include Proficiency Testing Providers (ISO/IEC 17043) and Reference Materials Producers ISO (17034).

The full list of signatories to the ILAC MRA is available from https://ilac.org/signatory-search/ .

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IAAC RECOGNITION TO THE ILAC MRA CONTINUED

As a result of the recent ILAC Arrangement Council ballot, the continuation of the recognition for the Inter American Accreditation Cooperation (IAAC) as a recognised regional cooperation body of ILAC has been confirmed. The endorsed AMC recommendation is shown below:


The ILAC AMC recommends that the scope of recognition of the IAAC MLA to the ILAC MRA be:
 

  • continued for the accreditation of calibration and testing laboratories using ISO/IEC 17025, medical testing laboratories using ISO 15189, inspection bodies using ISO/IEC 17020, proficiency testing providers using ISO/IEC 17043 and reference material producers using ISO 17034.
     

It is recommended that the next re-evaluation of IAAC is scheduled to begin no later than September 2025.

 

Information on the recognised regions including IAAC to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/

We look forward to continuing to work with our colleagues from IAAC.

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