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For Clinical Labs: How to Ensure a Consistent Supply of High Quality Reference Materials

Posted by Eric Morreale, PhD on Oct 29, 2019 12:00:00 PM

Healthcare is — to put it mildly — unpredictable. You never know when testing demands will change due to a disease outbreak, or a shift in medical consensus. Thus, clinical labs operate with a basic mindset: be prepared.

One area where you can’t accept unpredictability is with your source of quality control and reference material. Having the high-quality independent controls you need ready to go at a moment’s notice is critical for ensuring accuracy, maintaining efficiency, and upholding your lab’s reputation with clinicians and patients. Your choice of vendor, then, becomes crucial. 

 

4 Things to Look for in a Vendor for Third-Party Controls

The temptation is to choose an external controls vendor solely on price. While affordability is certainly one factor to consider when choosing a vendor, it’s far from the only one.

Besides price, here are a few characteristics to look for in a third-party control vendor:

 

1. A Long History as a Large-Scale Provider of Reference Materials to the Clinical Lab Market

Sourcing expertise is something that comes from experience. So is the deep network of suppliers a vendor must establish to provide its customers with a steady supply of high-quality reference material. Choosing a vendor that can reliably deliver the reference material your lab needs is critical to ensuring you avoid the dreaded backorder scenario that can bring lab operations to a halt.

Look for vendors with longevity and well-earned reputations as trusted partners to clinical lab professionals.

 

2. Intricate Knowledge of the Critical Characteristics of an Effective External Control

Finding a vendor that offers a stable supply of reference materials means little if the products are of poor quality, or do not do the job as intended. That’s why it’s important to select a vendor that also has the expertise to design robust controls that effectively monitor test performance over time. The first step is understanding the characteristics of high-quality external controls. As discussed in our recent article, “Avoiding False Positives and Negatives by Being a Control Freak,” an external control should have some core characteristics that enable it to effectively assess assay performance. These features include having a composition similar to the patient sample being tested, and having low positivity near the clinical decision point.

Other, less obvious features such as a ready-to-use format, extended shelf life, and multiple pack size configurations are important to help optimize testing workflows and inventory management. Unfortunately, not all vendors possess the knowledge and capabilities to manufacture controls in such a meticulous manner; be sure to select a vendor that does.

 

3. Responsive Technical and Customer Support Teams

Clinical labs have no time to waste. Whenever you’re faced with downtime, you’re not generating reportable results - meaning lost productivity as well as clinician dissatisfaction. You should choose a supplier that offers comprehensive, dedicated, and skilled technical and customer support teams. Whether it’s a highly technical question or a billing inquiry, you want to be able to reach your vendor quickly and minimize any potential downtime.

 

4. A Quality Control System as Rigorous as Yours

Just as you demand the highest levels of quality control within your lab operations, you should look for a vendor with that same commitment to quality.

Choose a vendor that has instituted a rigorous quality management system that ensures only product of the highest quality is delivered to customers. Look for certifications such as ISO 13485 (for medical device manufacturing) as a sign of this level of comprehensive quality system.

 

Other Ways to Improve Your Clinical Lab’s Efficiency and Accuracy

Choosing the right vendor to ensure a consistent supply of high-quality controls and reference materials is just one way to keep your lab running at maximum capacity and throughput with the highest level of accuracy. Find out more in our free guide for clinical lab operators, “Best Practices for Clinical Labs: Strategies for Implementing a Best-in-Class Quality Control System.”

 

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Topics: M&S