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 Quality Control – More than EQA
Did you know that Randox is the company behind the RIQAS EQA scheme? RIQAS (Randox International Quality Assessment Scheme) is just one area of our comprehensive Quality Control portfolio. As such it is our resolution this New Year to introduce Randox as the brains behind RIQAS and show you that we are more than just an EQA provider by sharing our passion for laboratory QC.
Who are Randox Quality Control?
At Randox we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets. With our extensive product offering comprising third party QC sera, interlaboratory data management software and calibration verification products, you can be sure that our complete QC solutions will provide you with a comprehensive overview of laboratory performance.
Seeing the complete picture with Randox QC
Acusera QC sera
As one of the largest manufacturers of true third party, commutable controls we deliver high quality, cost effective quality control solutions designed to accurately assess instrument performance and provide confidence in patient test results.
Acusera 24.7 interlaboratory data management
Acusera 24.7 enables you to drive for more accurate results by helping you to monitor and interpret QC data. With access to an impressive range of features, including the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics, Acusera 24.7 ensures analytical quality.
RIQAS EQA Scheme
RIQAS is employed by more than 45,000 laboratory participants in 124 countries. With frequent reporting you will identify errors sooner ultimately reducing the need to carry out preventable, expensive retests on a large volume of patient samples.
Acusera Calibration Verification sera and software
The Acusera linearity sets cover a wide range of clinical testing including; cardiac markers, therapeutic drugs and proteins. Designed with convenience in mind, the range ultimately helps you to meet CLIA requirements for calibration verification and the assessment of linearity.
Randox QC Resources Hub
Beyond selling laboratory QC we are also passionate about education, offering a range of educational guides, seminars and webinars, with more to come throughout 2017. Check out our QC resources hub for our current educational material and let us know what educational material you would like to see.
For more information, or to request a visit from one of our QC Consultants, contact us via acusera@randox.com.
IQCP: Where Are We Now?
What is IQCP?
IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.
IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.
Where are we now?
As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?
In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.
Opinions were mixed regarding the effectiveness of IQCP:
Positive Opinions of IQCP
- Some users found that IQCP decreased the number of QC materials required
- There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
- Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
- Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
- Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff
Negative Opinions of IQCP
- Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
- Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
- Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
- Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.
ISO 15189:2012 requirements
As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.
We would love to know your thoughts on the subject. Send us an email at acusera@randox.com.
References:
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Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.
Does Your QC Cover Clinically Relevant Ranges?
Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
Measuring the Complete Clinical Range
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.
Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”
What are Medical Decision Levels?
Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.
For example, the MDL of Glucose can indicate a certain diabetic status:
| Analyte | Medical Decision Level | Diagnostic Status |
| Glucose (fasting) | <100 mg/dL | Non-Diabetic |
| 100–125 mg/dL | Pre-Diabetic | |
| >125 mg/dL | Diabetic |
Competitor QC
Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:
Competitor Chemistry Control Level 1 – 68 mg/dL
Competitor Chemistry Control Level 2 – 134 mg/dL
Competitor Chemistry Control Level 3 – 386 mg/dL
In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).
Randox QC
Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:
Level 1 – 57 mg/dL
Level 2 – 114 mg/dL
Level 3 – 236 mg/dL
The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.
Immunoassay Medical Decision Levels
Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:
| Analyte | Medical Decision Level | Randox Level 1 IA Control | Competitor Level 1 IA Control |
| TSH | 0.1 or 0.27 uU/mL | 0.15uU/mL | 0.37 uU/mL |
| Vitamin B12 | 190 pmol/L | 174 pmol/L | 327 pmol/L |
| Ferritin | 12 ng/mL | 11.1 ng/mL | 49.6 ng/mL |
In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.
