Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations
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.
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
Randox receives UKAS ISO 17025 Accreditation for testing of SARS-CoV-2 (COVID-19)
Randox receives UKAS ISO 17025 Accreditation for testing of SARS-CoV-2 (COVID-19)
Randox Laboratories has today confirmed its UKAS ISO 17025 accreditation for the detection of the SARS-CoV-2 virus (COVID-19), granted on 7th October 2021.
UKAS is the National Accreditation Body for the United Kingdom and is appointed by government to assess and accredit organisations that provide testing services. Given the unprecedented requirement for nationwide testing over the past two years, the need for the public to have confidence in testing remains more important than ever.
Randox has been at the forefront of COVID-19 testing since the outset of the pandemic, is amongst the very largest COVID-19 laboratories in the UK and Europe, and to date has processed almost 20 million tests.
Today this final UKAS documentation confirms that Randox has continuously met all ongoing Government and UKAS requirements and submission deadlines, to remain fully active as a national COVID-19 testing provider, and listed on the Gov.uk website.
Randox, with almost 40 years of diagnostics experience, and multiple UKAS accreditations for a range of testing methods, is well placed to support the testing requirements associated with international travel.
To order a Randox home test kit visit covid.randox.com
For any enquiries on our Covid testing services please contact the Randox Covid Customer Support team on +44 (0) 28 9434 3005.
Related COVID-19 Products and Services
CERTIFLY LATERAL FLOW
HOME TEST - PCR
ANTIBODY TEST
LABORATORY TOOLS
ISO 22870:2006 in the Point-of-Care Testing (POCT) Market
Point-of-Care Testing (POCT)
The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;
“What are the challenges you face regarding POCT?”
“What do you see in the future for POCT?” (BIVDA, 2016)
Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.
ISO 22870:2006
The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).
With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.
For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;
“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”
How can Randox help?
Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.
We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.
Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel. Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.
Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation. With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!
By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.
