Medical Device Link.

Originally Published IVD Technology March 2003

Commentary

Robin E. Selder and Courtney T. Harris

Robin E. Selder is president and Courtney T. Harris is vice president of marketing and sales at eBonding Integration Services (Denver). The authors can be reached via rselder@medqualitycentral.com and charris@medqualitycentral.com, respectively.

Clinical laboratories have peer-based quality assurance (QA) programs that are an extension of their internal quality control (IQC) and give them a means of comparing their IQC values with those of other labs using the same instruments and methods. These programs also help IVD manufacturers validate product quality to support their own IQC programs.

A majority of IVD manufacturers also have processes and software to support peer-based QA programs. A high percentage of laboratories currently participate in manufacturer-sponsored peer-based QA programs, and most of these programs require participants to report instrument test-result information using paper forms. The reported data are transferred into a software system and statistically processed to generate results, which are analyzed and sent to participants. The peer-based reporting and results help to ensure that the products and instruments are producing predictable, reliable results. 

An obvious problem with the current process is that it is time-consuming for both manufacturers and laboratories. This process is also costly to manufacturers in terms of infrastructure and supplies. Furthermore, it takes up to 30 days for manufacturers to receive field performance data and up to 60 days for participants to receive peer-based results. With IVD manufacturers under increasing pressure to ensure the highest possible quality while being cost competitive, and clinical laboratories continuously faced with time and quality constraints, the current QA process needs to be improved. 

Finding a Solution

In an attempt to address these issues, some of the larger IVD manufacturers have developed Internet-based QA systems. However, these proprietary systems support only their own product lines and are often paid for by the end-user, either directly or through increased product costs. These systems work for some companies, but developing, deploying, and maintaining this type of service is cost prohibitive for other smaller manufacturers.

So how do IVD manufacturers deal with the mounting pressure to cut costs, adhere to government regulations, and improve the quality of their products? The answer is collaboration, specifically through an on-line information network that all manufacturers and laboratories can access. 
Before such a network could come to fruition, the laboratories first had to get their technology up to speed. In early 1999, eBonding Integration Services (eBIS; Denver) was contracted to design and build a Y2K-compliant QA system for an IVD manufacturer. In analyzing the needs of the client and its customer base, it was apparent that an Internet- or e-mail-based system would provide the most accurate results, the best turn-around time, and cost savings. However, at that time, many labs did not have Internet access, so it was determined that they were not ready for on-line collaboration. Three years later, the number of labs with Internet access had jumped to over 90%. Hence, it is clear that labs are ready for on-line collaboration. 

Creating a Network

Establishing a collaborative on-line information network would enable laboratories and IVD manufacturers anywhere in the world to participate in a centralized peer-based QA service. Such a network would also offer technological benefits, including real-time processing, feedback, and validation. 

By using a collaborative network, IVD manufacturers would realize cost savings through process automation and economies of scale. They would be able to free up resources to focus on developing new products instead of using them to support their current product lines. In addition, by eliminating the manual data entry of QA information, manufacturers can automate and streamline workflow, and can reap the benefits of being involved in response to product issues because they are able to track field performance on a real-time basis. 

At the same time, laboratories would save time by having a single system for all of their QA recording and reporting needs. Labs would no longer have paper forms from numerous manufacturers in many different formats to complete each month.

Toward this effort, eBIS conceived and developed Med Quality Central, an on-line collaboration for IVD quality assurance. A free service to clinical laboratories, this Internet-based, product- independent QA application service provides access to real-time QA information and can support virtually any combination of IVD products to build peer groups.

For example, laboratory users can select from premade lists of manufacturers and products in order to join or define peer groups they want to track. The system then builds a set of links between the selected products to form the group. By doing so, laboratories can report data for many different products and manufacturers to one service, thus centralizing their QA programs. Each laboratory user also has its own secure home page where it can record test-result values, view current statistics, and generate historical reports. These historical performance reports are produced through an array of histogram and plot reports, and can be rendered based on user-defined intervals and date ranges. 

Sponsoring manufacturers have their own secure home page where they can set expected range values, lot expiration dates, and track their product peer groups on a real-time basis worldwide, consequently enabling them to have data access and generate reports for each product. Through the system, manufacturers can send electronic broadcasts to notify their customers of service sponsorship and product information (e.g., value sheet changes). Manufacturers also have the option of supplying baseline peer group information to reflect current statistical values, thus preserving previous historical data. 

Conclusion

Recent studies have shown that medical errors are often the result of systems errors, clinical errors, delivery organizations, and how resources are provided in the delivery system. Improving the process and quality of healthcare by reducing these industry errors is certainly a worthy goal. In order to do so, transforming quality assurance at the fundamental level of providing healthcare is where processes and procedures need to be changed. Using a centralized service to track the quality of IVD products will help streamline QA and facilitate achieving this goal.

Med Quality Central is targeted for release at the end of the first quarter of 2003. For more information about this service, please access its Web site at http://www.medqualitycentral.com, or contact eBIS at 303/346-0415. 

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