UKAS ISO15189:2022 Transition Update

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UKAS ISO15189:2022 Transition Update

Throughout 2023, UKAS have been hard at work training Assessment Managers and Technical Assessors on the new requirements of the updated ISO15189 guidelines, sharing information about the updated standard and developing the UKAS 15189:2022 Transition Hub providing a one-stop-shop for information on the ISO15189:2022 update.

Recently, UKAS have published a Transition update to remind laboratories of where they stand in seeking their updated accreditation.  In this update, UKAS state “As per the UKAS transition plan, all assessments due to take place from the 1st January 2024 will be to ISO15189:2022.”

A gap analysis will be required one month prior to transition assessments, detailing the gaps and the actions which have been taken to remedy these gaps. This should include evidence, such as updated documents and records, embedded in the gap analysis document, showing what action has been taken to bring a laboratory’s practices in line with the updated standard.

An important note included in this transition update is , “UKAS cannot grant accreditation on intent; organisations shall make the necessary changes and have implemented these prior to the transition assessment.” So if your accreditation assessment is due soon, you might want to make use of our ISO15189:2022 Accreditation Guide to assist you in your gap analysis to ensure you don’t miss out.

This is crucial for laboratories because failure to align with the 2022 version of the standard before the deadline of 6th December 2025 will result in a suspension of ISO15189 accreditation for up to 6 months.

Some of the key accreditation updates include:

You can find more information to assist in your gap analysis and achieving ISO15189:2022 accreditation our ISO15189:2022 Accreditation Guide – a free PDF is available below.

Randox Quality Control’s Acusera range provides true third part quality controls designed to help you achieve all aspects of ISO15189:2022 accreditation including commutable matrices containing consistent, clinically relevant concentrations with unrivalled consolidation of analytes. To learn more about our range of quality control products, visit our website or, get in touch today at marketing@randox.com


Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations

We are thrilled to present two educational guides that delve into the newly updated minimum performance specifications for Proficiency Testing by CLIA (Clinical Laboratory Improvement Amendments). These regulations, set to be implemented by 2024, aim to enhance the accuracy and reliability of test results in clinical laboratories. Here, we introduce these invaluable resources designed to assist laboratories in navigating the evolving landscape of proficiency testing.

1. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology):

Our first guide focuses on the specific regulations and requirements pertaining to microbiology proficiency testing. With a comprehensive exploration of these guidelines, this guide is a useful resource for microbiology labs striving to ensure precision and integrity in their testing procedures. From the required categories of testing to maintaining optimal testing conditions, the guide details the updates that promote adherence to the highest standards of quality and safety.

2. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):

For non-microbiology laboratories, our second guide delves into the updated proficiency testing regulations concerning various analytes. From chemistry to haematology, molecular diagnostics to immunology, this guide offers a comprehensive overview of the new requirements and minimum performance specifications. By embracing these regulations, medical laboratories can uphold the utmost accuracy and reliability in their test results, ensuring optimal patient care and clinical decision-making.

Elevating Laboratory Practices:

These educational guides are indispensable tools that empower laboratories to navigate the changing landscape of proficiency testing regulations. By staying informed and adopting the updated minimum performance specifications, laboratories can maintain compliance, demonstrate excellence, and ultimately deliver the highest quality of care to their patients.

Accessing the Guides:

We invite you to access these comprehensive educational guides by following the link provided below. They offer a wealth of knowledge and practical insights, serving as essential references for laboratory professionals, quality managers, and anyone involved in clinical diagnostics.

Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology)

Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):

With the implementation of updated CLIA proficiency testing regulations on the horizon, these educational guides come at a crucial time. By embracing the knowledge and guidance they provide, laboratories can navigate the changing landscape with confidence and ensure their adherence to the highest standards of proficiency testing. Together, let’s strive for excellence, precision, and patient-centric care in clinical laboratory practices.

#CLIARegulations #ProficiencyTesting #ClinicalLaboratories #QualityAssurance #PatientCare

Microbiology

Non-Microbiology


QC Industry Articles & White Papers

A simple swab test developed by Randox scientists could help curb the antibiotic resistance pandemic.

The test, which can rapidly detect and identify the cause of 21 respiratory infections in just 5 hours, can subsequently determine the appropriate antibiotic drug treatment for patients.

Following the Lancet Infectious Diseases report last week that antibiotic resistance is growing at a rapid rate, with many ‘superbugs’ completely unresponsive to antibiotics, it is more important than ever that antibiotics are only prescribed when they will effectively treat an infection.

With 70% of GPs admitting that they prescribe antibiotics when they are unsure if they are treating a viral or bacterial infection, many patients are therefore taking antibiotics when they are ineffective in treating viral infections.

Given that only bacterial infections can be treated with antibiotics, rapid diagnostic tests are urgently needed to identify bacterial and viral infections.

Professor Peter Coyle, who leads one of the UK’s Regional Virology Laboratories in Belfast diagnosing infectious diseases, warns against antibiotic misuse:

“The commonest types of respiratory infection are of viral origin and antibiotics are ineffective in their treatment. Improving the diagnosis of respiratory infections is an important goal in improving patient management and reducing antimicrobial resistance. The threat of antimicrobial resistance and the loss of effective antibiotics has become a major and growing concern in health care provision.”

The new rapid and accurate test will give both patient and GP confidence of their diagnosis of respiratory infections and will allow for quicker treatment if necessary.

Making this test available through GPs would have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.

John Lamont, Chief Scientist at Randox Laboratories, whose team developed the test, commented;

“Current diagnostic testing for respiratory infections take at least 36 hours to confirm the nature of an infection, and they cannot name and categorise infections as bacterial or viral in the way that this new respiratory test can. C-reactive protein tests, for example, that are currently in use can only indicate whether a bacterial infection is likely. We need more than just guess work to combat the antibiotic resistance pandemic.”


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