Understanding Proficiency Testing

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Presented by:
• Patricia Atkins – Senior Applications Scientist Spex®, an Antylia Scientific company

In this webinar you will:

  • Understand the purpose and function of a PT
  • Review best practices for preparing for and running a PT scheme
  • Learn the appropriate steps to take to pass a PT and items to consider when rerunning a failed PT or examining a non-compliant PT result

Who should attend:

  • Elemental spectroscopists working with AA, ICP, ICP/MS, IC and other elemental techniques
  • Analysts working in chemical, microbiological and molecular biology analytical laboratories
  • All laboratory chemists and technicians required by their QMS to perform PT testing

The announcement of a proficiency testing (PT) round, or scheme, can invoke a variety of responses from anxiety to resignation. Very few analysts look forward to performing these checks and sometimes feel they are being put on the spot and judged. In fact, a PT is used to evaluate laboratory and analyst performance, but it is not analogous to those dreaded college finals which one had to pass; instead, it is a tool of a quality management system to review methods and performance to weed out error and improve laboratory functions. This webinar will look at the best practices for achieving the passing results for PT analysis and tips on what to look at when challenged by a PT.

There are several key components of an analytical laboratory’s QA/QC including the use of CRMs, use or development of validated methods, and the implementation of a PT scheme. PT is a series or schemes of samples which are intended to test the performance of individuals or laboratories in specific areas or for specific tests. In this webinar, we will examine the role of a PT and look at the development, rationale and best practices for PTs including how results are derived and what those results reflect as far as laboratory performance.

Presenters

Your presenters for this webinar

Patricia Atkins – Senior Applications Scientist Spex®, an Antylia Scientific company
Patricia Atkins is a Senior Applications Scientist. She is a graduate of Rutgers University in NJ and was laboratory supervisor for Ciba Specialty Chemicals in the Water Treatment Division. Patricia later accepted a position conducting research and managing an air pollution research group within Rutgers University’s Civil & Environmental Engineering Department. In 2008, Patricia joined Spex as a senior application scientist in our certified reference materials’ division and spends her time researching industry trends and developing new reference materials. Patricia has been involved with many industry-focused advisory and regulatory groups including AOAC, ASTM, ACIL, NACRW and the Emerald Conference. She is a frequent presenter and speaker at numerous conferences including NACRW, NEMC, Pittcon and AOAC. She is a published author with her work appearing in various journals and trade publications including Spectroscopy, LCGC and Cannabis Science and Technology where she is a columnist for analytical issues in cannabis testing.

Your presenters for this webinar

Lauren Stainback – Global Product Manager and USP PT Coordinator NSI Lab Solutions
Lauren Stainback is the Global Product Manager for NSI Lab Solutions Inc. Lauren leads NSI’s product and business development efforts. Formerly a forensic lab director, Lauren has 15 years of experience within clinical and analytical laboratory science. She provides technical support and product development for molecular biology, pharmaceutical science, analytical chemistry and microbiology. Lauren is focused on supporting customers and distributors through technical support, applications training and new product development.

Your presenters for this webinar

Donnell Charles –Sr. Manager Proficiency Testing Programs USP
Donnell graduated with a doctorate in public health from Columbus University, MBA from Western Governors University and a Masters in biotechnology from Johns Hopkins University. In his current role, he directs and oversees the development of the USP Proficiency Testing Program physical materials, methods, pricing, publication, coordination, and co-marketing of PT studies in association with NSI Lab Solutions Inc., an Antylia Scientific company. He has 20 years of experience in the quality management system, ISO and proficiency testing and international laboratory systems development in PQM at USP. Donnell has had professional stints in Human Genome Sciences, FMC, Actavis, Battelle, and the FBI.


Questions & Answers from the live event

Any advice for blind PTs; those which need to be developed in-house because they cannot be purchased from a reputable supplier?

NSI Lab Solutions developed their ISO 17043 scope of accreditation to allow us the flexibility to create new and custom proficiency tests for specific customer needs. We can look at a customer’s unique need and determine if it is something that we can offer as a custom PT, or if it is available but advertised for a different industry and/or application.

Just to understand, the target (assigned reference value) of the PT is not determined by all the labs or the mean of the labs, but by a certified laboratory, right?

As you are aware, scoring of proficiency test participants can be accomplished by many data analysis methods. The ISO 17043-accredited PT provider is required to determine the best approach for scoring/grading the participant results. Robust means can provide a useful consensus where the underlying distribution is roughly symmetric with 0 to 10% outliers in the data set.

Additionally, Z-scores based upon fitness for purpose can be used. Participant results can be compared with both reference values, given by accredited providers, and robustly calculated consensus values. NSI Lab Solutions primarily uses Z-scores and robustly calculated consensus values. Robust statistical evaluations, regarding reference values, are infrequently used for custom and new proficiency test schemes or situations where there are few participants.

How many lab analysts can be tested per order?

Generally, one order is placed per analyst in duplicate or two analysts with one analysis each.

How much material is provided in each order of a PT sample?

Enough material to perform two replicate tests.

How do I find the instructions for the Proficiency Tests [items] I want to order?

Instructions are available to download from our website. Visit www.nsilabsolutions.com and navigate to proficiency testing at the top menu, and then select instructions from the drop- down menu.

My lab is based outside of the US. Can I perform your proficiency tests if I use analytical methods from the European Pharmacopoeia Commission?

Yes, our proficiency tests can be performed using alternative pharmacopeia such as EP or JP. Simply select “Other” from the Method of Analysis drop-down menu when entering your PT results in the USP PT Portal.

What does the ISO 17043 accredited mean?

ISO 17043 accreditation means that the PT testing schemes provided by the PT provider conform to the guidelines for conformity assessments and PTs. See NSI website for more information.

How does a lab select which PT studies to participate with?

Labs must understand if the PT selected is:

  • fit for use or purpose determined by the lab
  • based on scope of accreditation
  • chosen for an expectation of expanding scope
  • used to correct or risk actions mitigation
  • supporting continuous improvement

If you fail a study, what are the next steps?

Follow the current in-house procedure for CAPAs or risk. Investigate to eliminate the issue or errors. Double-check the calculations and the investigation. Follow up and provide retraining if needed.

Can PT studies be used for other purposes?

They can be used for risk mitigation, onboarding/authorization, corrective action, scope expansion, maintaining accreditation or qualification.

Who can review PT results?

PT results are confidential between the provider and the participant. The results can only be shared by the participant if it is required by an accreditation body or regulator.