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:

1. Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.