Laboratory Metrics: Beyond QA and Risk-Control, and into the World of Marketing

Before a potentially life-saving drug can be used to treat patients, it must be proven to be safe and effective to treat the illness for which it is intended. Drugs must be reviewed and approved by a regulatory agency set up for that purpose. In the United States, that agency is the Food and Drug Administration (FDA). It is the responsibility of the FDA to decide whether or not to clear a treatment for a specific indication in the United States. That determination is based on copious amounts of scientific and technical data aimed at demonstrating the safety and efficacy of the drug. However, before the FDA will even consider a drug for approval, the process by which the drug is evaluated must meet high quality standards. A drug cannot be assumed safe and effective if the laboratory testing environment where pivotal test data were generated cannot demonstrate high levels of quality assurance, technical and scientific competence, and process oversight in order to control risks.

Thus, the lab must have established good quality metrics — a system of measurements and monitoring — in accordance with or above industry standards. Furthermore, these standards must be thoughtfully established. Laboratories that engage in the commercial business of clinical trial testing must also be profitable. It is important that laboratories be able to effectively market their services, in part by getting their quality message to the market place.

History
These issues have permeated the laboratory testing industry since the mid-20th century. External quality assessments (EQA) and proficiency testing (PT) by outside organizations, such as the College of American Pathology, began to gain prominence shortly after this time.

In the mid-to-late 1980’s, news reports shed light on errors associated with measuring serum cholesterol and other analytes. The federal government responded by passing the Clinical Laboratory Improvement Act (CLIA) to “establish quality standards for all clinical laboratories throughout the U.S.” In 1992, Congress heard testimony from victims of faulty laboratory testing and inaccurate Pap smear results, and then published the CLIA Amendments. This Public Law, CLIA-88, expanded the Department of Health and Human Services’ authority to allow it to regulate “any laboratory that tested specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.”

Nonetheless, the question remained as to how different tests could be measured against the same criteria for safety, quality and accuracy.

The answer was that they could not. As a result, during the last 10 years, two new phenomena have emerged: the increasing use of metrics data by laboratory organizations to market their quality and ability to control risk to boost sales as a top-tier research partner; and the growth of industry “pockets” or consortiums joining to establish their own criteria to be met by member laboratories.

Thus, groups of companies with similar missions or focus areas are increasingly developing metric systems - industry standards for measuring the performance of laboratory service providers. This allows the pharmaceutical industry the opportunity to compare metrics that monitor information from central (clinical–trials) laboratories in a more uniform manner.

Labs turn proactive
Whether self-regulated or influenced externally, any laboratory conducting clinical testing must establish a system for measuring laboratory metrics that ensure quality, efficiency, proper control, and continuous performance improvement. These metrics are usually set and monitored by individual laboratories, based on what testing services are provided. Pharmaceutical companies and industry watchdogs determine whether the lab’s metric system meets their expectations for quality assurance and risk-control. With the testing facility striving to become the laboratory of choice and the drug developer eager to become the treatment provider of choice, outside pressures contribute to the overall improvement of drug-testing practices and, consequently, the improvement of the drugs themselves.

Clarifying the system
Laboratory performance metrics systems involve establishing a set of monitoring parameters for quantitatively and periodically measuring multiple processes within an organization. Besides defining what a laboratory will measure, the metrics system also describes how the laboratory will collect and analyze the data against some predefined target limit. If a certain metric exceeds an allowable defined limit, action is taken to remedy the problem followed by further monitoring to demonstrate that the problem has been resolved. Thus, a metric is a specific performance monitor that can be measured on an ongoing, consistent basis and which provides information concerning the quality, accuracy, effectiveness and efficiency of an identified process or procedure.

Laboratories that can demonstrate better performance are in a better position to shepherd more drugs through the regulatory process. Demonstrating this to pharmaceutical and biotech customers should result in more business as a result of solid quality assurance practices.

As a new laboratory company aiming to meet or exceed QA and risk-control standards, there are three steps that should be taken:

Three steps to success
1. Find out if there is already a movement afoot. Often, professional organizations or societies are neutral ground for exploring these situations. While there is indeed strong competition, and each laboratory is competing for the same product, labs all want to know they are competing on the same field.
2. Ensure that the metrics monitoring system your laboratory has in place covers the full extent of services and processes you are engaged in or provide. Make sure that your scope is broad enough to minimize risks and properly ensure quality.
3. This is a marathon, not a sprint. Your laboratory must be committed and focused on quality. The data generated in a solid metrics system needs to be conveyed to external customers in a clear and convincing manner in order to gain credibility. This is a very important message both from a performance and marketing prospective.