Data management in QC

The management of quality control results has reached the 21st century. Technology such as good internal quality control (IQC) data management software offers laboratories a higher level of efficiency and ensures correct results collection. 

Laboratories are faced with many questions when examining QC results and deciding if they are acceptable or not. Without effective management of QC results, laboratories are at risk of producing erroneous patient results. 

Examining IQC data can often be a subjective matter. Laboratorians agree that they need to acquire an in-depth understanding of their IQC results over time. Factors such as the stability of the assays can have a significant bearing on how frequently IQC is run. Consideration must be given to such factors to ensure that labs have appropriate QC procedures in place.  

Examining results manually is a time-consuming process that can be costly for the laboratory. Deciding whether a result is acceptable or not can be time-consuming, and re-running controls that didn’t need to be re-run can waste money. Also, significant problems can be overlooked when unacceptable IQC results are not recognized.  

Good data management software provides laboratories with a window to view their performance over time. The use of QC multi-rules, available through data-management platforms, will advise whether to accept or reject the QC result based on the laboratory’s QC history. With the added benefit of peer-group data sharing to monitor performance, the lab is able to call upon results from multiple laboratories running the same test, providing a head start in identifying a potential issue. 

Web-based data management software allows laboratories to effectively manage, interpret, and compare IQC data to their peers in real time. This means the laboratory is no longer viewing the unexpected results in isolation. Labs can view the performance of their peers, facilitating speedier troubleshooting and resolution. 

In brief, data management platforms can help laboratories:

• identify trends, instrument errors, or reagent issues as soon as they arise, assuring validity and increasing confidence in the accuracy of results.
• optimize error detection, minimize costly repeat tests, and reduce false rejections through the use of multi-rule QC procedures.
• improve PT performance by eliminating any undetected bias.
• ensure confidence in assigned target values.
• facilitate regulatory requirements and meet ISO 15189 accreditation which states that “The laboratory shall participate in inter-laboratory comparison programs.”

Data management and IQCP

The new IQCP guidelines consist of three key components: risk assessment, quality control plan, and quality assessment. To assist in implementing an IQCP, it is advisable to take advantage of data management software, because it consolidates internal QC data into one place. It can also help laboratories ensure that errors are not just identified but appropriately documented, monitored, and acted upon to prevent future inaccuracy. 

Data management plays a vital role in fulfilling the risk-assessment requirements described in the Center for Medicare and Medicaid Services’ (CMS) IQCP guidelines. According to the new IQCP guidelines, the risk assessment should support the frequency of testing control samples. Using data management software, laboratories can identify the stability of an assay over time and therefore decide the appropriate frequency of quality control. (Manufacturers’ recommendations, along with accrediting  organizations’ requirements, should be factored into this decision.) 

In addition to risk assessment, a data management program can perform a critical function in implementing the quality control plan. CMS states that the “QCP must at least include the number, type and frequency criteria for acceptable results of the quality controls.”¹ Many data management software packages have multi-rule functionality that can automatically be applied to QC results. Using multi-rules, laboratories can clearly distinguish an acceptable result from an unacceptable one. 

Data management and POCT

IQC in point-of-care testing can be tricky to manage. While effective IQC procedures are well established in laboratories, the monitoring of results outside of the laboratory is uncharted territory for many of those involved in POCT. Laboratory managers are ultimately responsible for managing IQC in the point-of-care setting; however, many struggle to find effective IQC solutions that are suitable for multiple locations and operators unfamiliar with IQC. How do laboratory managers monitor results in remote sites? How can results be monitored from a variety of POC users and devices? How does the lab ensure this process is both cost-effective and efficient?

Online data management can provide a good solution, helping overcome all of the above issues by facilitating the monitoring of POC results anywhere that internet access is available. Every POC device throughout the clinical setting should be registered on the data management software. Results can be entered in a variety of ways—on PCs, laptops, tablets, or smart phones—and once this is done the software will automatically accept or reject the results based on the performance of the control. This offers POC users a simple and effective way to ensure that their POC device is “in control” and that the results produced are reliable.

Results from multiple analyzers are stored together in the software, making it convenient for lab managers to review results. By logging onto the software, the laboratory manager can review and compare results from all POC devices around the hospital or even across multiple sites. This provides lab managers with a comprehensive overview of test performance across the entire clinical setting, without having to leave their desk. This gives a long-term view of how each device is performing, helping lab managers to identify any maintenance issues or training needs of the operators.

Available online data management platforms offer different levels of user access. This means that POC device operators will have their own unique log-in ID and can have restricted access to the software’s functionality. For example, users can only enter results, not edit or delete them. Many of the software packages available will calculate internal statistics such as the mean and CV, displaying trends in IQC data. In addition, the peer-group function gives the laboratory visible results produced by other users globally, using the same POC devices.

The cost-effectiveness and efficiency of monitoring POCT devices with online software is perhaps one of the most beneficial aspects of the platform. Some providers offer unlimited instrument registrations free of charge, allowing the laboratory to register all of its POC devices on one licence. With the right online data-management system in place, meeting IQCP requirements and ensuring effective monitoring of internal quality control, both in and out of the laboratory, could get significantly easier.