Case Study: Sentara Laboratory Services

The buzzword in the health care industry is quality. But what does it mean and how is it applied in clinical laboratories? Laboratories that build strong quality management systems have the ability to meet regulatory and accreditation requirements, which results in the ultimate goal of improved patient care.

Clinical and Laboratory Standards Institute (CLSI) is striving to help laboratories implement and manage quality initiatives and guide future quality improvements with its January 2007 release of The Key to Quality. This product—designed to assist clinical laboratories with creating, implementing, and refining a quality management system—has been put to the test at one organization, Sentara Laboratory Services.

In the case of Sentara Laboratory Services, an extensive quality system was already in place for the hospital; however, new full-time employees were recently hired to build and enhance a true quality management program specifically for laboratory services.

Knowing that a quality department in laboratory services was being built, Lou Ann Wyer, MS, MT(ASCP), Clinical Specialist, POCT, Sentara Laboratory Services, looked to CLSI to find a resource for the newly hired quality coordinators. “We decided to utilize The Key to Quality in order to transition our current quality plan into something that is much more detailed,” says Wyer.

According to Wyer, “The Key to Quality is so easy to follow. Because navigation through the product is so intuitive, it is a very good resource to have whether you are starting a quality program or want to enhance an existing program. We anticipate that our end product will be an easy-to-follow resource for both laboratory management staff and laboratory technical staff to understand.” She adds, “What The Key to Quality brings that we did not have with our existing policies and procedures, is the connection and classification of quality system essentials (QSEs).”

CLSI has identified 12 QSEs, which are the fundamental components used to establish any quality management system. The Key to Quality showcases the implementation of all 12 QSEs. It includes a slideshow to introduce the CLSI concept of quality management, practical examples and templates for each of the 12 QSEs, cross-reference approaches from other organizations, flowcharts, self-assessment checklists, and a CD-ROM with additional quality management tools.

When asked whether The Key to Quality helps laboratories that are interested in building or enhancing a quality program save time, Wyer says, “The way the information is presented in this product is so user-friendly. The templates, the CD-ROM with examples, and the examples in the workbook are straightforward and can be applied to your program quickly and easily.”

“The product has allowed us to look at our processes from beginning to end,” comments Wyer. “Now, we are doing process mapping. Most people benefit from flowcharts, especially visual learners. They are able to understand the process through the visual cues rather than just reading what should happen. Once you have a well-defined and correct process map, the policies and procedures fall right into place.”

Overall, Wyer notes, “The way The Key to Quality is formatted makes it practical for any level of person with any interest or an assignment to build a quality program. The real-life examples are helpful and useful to laboratories. It streamlines the development of a quality program—the research has already been done and is arranged nicely in this product. I can’t imagine putting together a quality management program in any way that is easier than using this product.” And, she adds, “It helps us meet our regulatory and accreditation requirements.”
 
In August 2007, CLSI published a complementary series of 12 Key to Quality Checklists. The checklists, available in tablet format, focus on laboratory quality system essentials to ensure that laboratories are documenting, implementing, and monitoring best-practice laboratory procedures and performance to facilitate compliance and accreditation.

For more information about The Key to Quality, Key to Quality Checklists, or other CLSI quality management systems documents or products, visit www.clsi.org. [ return to top ]