MAR24 - Meeting Accreditation Guidelines with Acusera 24.7 - blog header

At Randox Quality Control, we are never finished shouting about how great our interlaboratory comparison and peer group reporting software is. If you’ve had a look yourself, you’ll know exactly why. Acusera 24.7 is full of fetching, interactive charts, and useful, detailed reports, including measurement uncertainty, to help you streamline your QC procedure.

But Acusera 24.7 is so much more than this. Our team are constantly looking for innovative ways to update and improve our live, cloud-based software. Much of this comes from talking to our subscribers and finding out what they want and how they want to do it. Our team also happens to include some serious accreditation enthusiasts. So, we decided to put their passion to work. We’re regularly coming up with new measures to make meeting the guidelines set out by various accreditation bodies, including ISO15189, as simple for you as we can.

In this article, we’ll look at some of the accreditation requirements and the features we’ve included in Acusera 24.7 to simplify the process for you.

QC management tools

Its one thing to look at the features of Acusera 24.7, but what do the various guidelines have to say about QC management tools? Let’s look at some of the major accreditation literature.

ISO15189:2022

The new version of ISO15189 includes updates which aim to place more emphasis on risk management and mitigating risk to the patient. Here’s what the 2022 version has to say about QC management tools:

“e) the resulting data shall be recorded in such a way that trends and shifts are detectable and, where applicable, statistical techniques shall be applied to review the results.

f) IQC data shall be reviewed with defined acceptability criteria at regular intervals, and in a timeframe that allows a meaningful indication of current performance.”

ISO15189:2022 section 7.3.7.2

The Clinical Laboratory Improvement Amendments 1988 (CLIA)

CLIA ’88 regulations are federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. These regulations state the following related to QC management:

“Lab surveys by CLIA accreditation bodies will request quality control records including:

a) Remedial action information; …

c) Statistical limits; and

d) Instrument maintenance and function checks records.”

4.93.1105 Standard: Retention requirements (a)(3) Analytical system records.

“Retain quality control and patient test records (including instrument printouts, if applicable) … for at least 2 years. The records must include charts, graphs, printouts, transcribed data, and manufacturers’ assay information sheets for control and calibration materials.”

CLIA Amendments 1988

COLA Accreditation

The Commission on Office Laboratory Accreditation (COLA) is another recognised laboratory accreditation in the U.S. and is a third-party accreditation organisation that ensures laboratories comply with federal regulations, including those set by CLIA. I’m sure you’re catching the trend here:

“Identification of individuals performing QC should be available in the QC records.”

“The Surveyor will review QC records, corrective action logs, reagent logs and maintenance or service records to make sure that controls were tested and acceptable. Documentation should include date of testing, initials of the individual performing, actual results and indication of acceptability.”

“The Surveyor will look for QC in a graphic format. Data may be graphed as Levey-Jennings Chart or similar graphic representation and reviews of graphs should be performed at least every 5-7 days of testing. The graphs do not have to be printed.”

“If there are shifts or trends demonstrated in the data, the Surveyor will expect to see notation by the staff and should be able to follow the documentation trail to corrective action that is taken, as required by the laboratory’s QC policies.”

“Control charts, graphs, or statistical parameters (i.e. mean, SD and CV) should be maintained for all quantitative tests performed by the laboratory. This data should be reviewed weekly or following every 5-7 data points if performed infrequently to detect changes such as shifts or trends that may be indicators of test system problems that need to be addressed.”

“The Surveyor will review QC records for evidence of review – including initials/signature and date of the review. Reviews should take place at least on a monthly basis. If data point(s) fall outside the acceptable ranges, notation, and corrective action, if necessary according to the laboratory’s QC procedures, needs to be include in the review.

Corrective actions may include such actions as opening a new bottle of QC, replacing the reagent, or recalibration. Trends and shifts in QC should be noted as well.”

COLA Accreditation Manual, Section 3 – QC

Meeting accreditation with Acusera 24.7

Acusera 24.7 offers a flexible approach to help laboratories meet all the QC accreditation requirements detailed above, including CLIA, COLA, CAP, and ISO15189.

Our user-friendly, cloud-based software allows users to effortless run statistical analysis including Coefficient of Variation Index (CVI), Standard Deviation Index (SDI), % Bias, Total Error, Sigma Metrics and more! Find out more about how we can aid you in your statistical analysis in our blog, Advanced Statistics with Acusera 24.7.

Acusera 24.7 can also create fully interactive Levey-Jennings charts, and a selection of histograms to provide a wide range of options for the graphical representation of your data. The interactive features of our charts allow you to record events such as lot changes and calibration events directly on to the chart, helping you achieve not just accreditation, but a better understanding of what is going on in your laboratory. You can read more about our charts and the insights you can gain from them at our blog, Charting the course to laboratory excellence.

Acusera 24.7 can also provide you with a variety of reports to help you effortlessly achieve accreditation. From our Statistical Analysis and Exception reports to our Personalised Performance Summary Reports, we can help your laboratory to efficiently identify and document trends or shifts in performance. You can read all about our reports in our blog, Effortless Data Management: Acusera 24.7 Reports.

Measurement Uncertainty

Anyone involved in laboratory quality control will be aware of measurement uncertainty (MU), although that doesn’t mean everyone understands this tricky requirement. MU is defined as a parameter associated with the result of a measurement that characterises the dispersion of values that could reasonably be attributed to the measured quantity.

In other words, MU provides medical laboratories with an estimate of the overall variability in the values they report. The goal of MU is to quantify the doubt or range of possible values around the measurement result, helping to provide an understanding of the reliability and limitations of measurements. This helps ensure measured results are useful and not wildly inaccurate, allows meaningful comparisons with medical decision limits and previous results of the same kind in the same individual and finally, it’s a requirement of ISO15189:2022:

“a. The measurement uncertainty (MU) of measured quantity values shall be evaluated and maintained for its intended use. The MU shall be compared against performance specifications and documented.

b. MU evaluations shall be regularly reviewed.”

ISO15189:2022 Section 7.3.4

Calculating MU is no simple task and not one that can even be attempted without in depth know-how. These calculations can take a single member of staff 2 full working days to complete. That’s a lot of time away from their normal duties, especially if MU is to be reviewed regularly, as per ISO15189:2022.

Lucky for you, Acusera 24.7 can calculate you MU in seconds, rather than days, and provide you with a report. This report can be shown to your accreditation surveyor, and you can consider the MU box ticked. You can read more about Acusera 24.7 and MU in our Advanced Statistics blog, or in our educational guide How to Measure Uncertainty.

Peer Group Reporting

The peer group reporting features of Acusera 24.7 are much more than just an added extra. Peer group reporting can help speed up the troubleshooting process, allowing you to determine whether an issue you are seeing is unique to you, or evident in the QC data of your peers. It can also provide you with more confidence in assigned target values and help make significant savings by improving your analytical performance, and therefore, your EQA performance.

A peer group reporting programme can also help meet regulatory requirements, like ISO15189:2022:

“ a. The laboratory shall monitor its performance of examination methods by comparison with results of other laboratories. This includes participation in EQA programmes appropriate to the examinations and interpretation of examination results, including POCT examination methods.”

“f. When an EQA programme is either not available, or not considered suitable, the laboratory shall use alternative methodologies to monitor examination methods performance.

NOTE Acceptable alternatives include:

– Interlaboratory comparisons of the results of the examination of identical IQC materials, which evaluates individual laboratory IQC results against pooled results from participants using the same IQC material.”

ISO15189:2022 Section 7.3.7.3 External quality assessment (EQA)

So, if you’re struggling to find a suitable EQA programme for your analytes, you might just be able to meet your accreditation with the peer group reporting features included in Acusera 24.7.

We’ve only begun to cover the features of this intuitive and efficient software. If you still aren’t convinced that Acusera 24.7 is right for QC data management in your laboratory, reach out to us today at marketing@randox.com. We’re always delighted to hear from you, and we’ll be happy to discuss any of the features of Acusera 24.7, or any reservations you may have.

Our customers can’t believe the gulf in class between Acusera 24.7 and other QC data management programmes.

Don’t get left behind.

Reach out to us today!

Posted on 29th February 2024 at 4:18 pm.

Written by Jason Armstrong

Meeting Accreditation Guidelines with Acusera 24.7