Medical Laboratories Receiving Waived Testing

By Author: Mary Rusk
Total Articles: 5
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You may not visit a medical facility, including your private physician's office, one or more times a year. However, if you start to experience symptoms of an illness, injury or disease, you may likely not only visit a medical facility, you'll also trust that the facility meets federal and local safety regulations, rushing in to receive care without giving it a second thought. Being treated at a facility that has undergone and passed a medical certification or accreditation could increase your confidence. Yet, not all medical facilities are required to undergo certain types of medical inspections, qualifying for waived testing.

According to the United States Centers for Disease Control and Prevention (CDC), "Laboratory testing plays a critical role in health assessment, health care, and ultimately, the public's health." The CDC continues, "An estimated 7 to 10 billion laboratory tests are performed each year in the United States, and laboratory test results influence approximately 70 percent of medical decisions."

Due to technological advances, the numbers of medical testing that can be ...
... performed quickly and easily using hand held devices is increasing. Regardless of the types of equipment they use to perform medical tests, all laboratories located in the United States that are used to perform tests on human specimens in order to diagnose or treat medical conditions are required to meet Clinical Laboratory Improvement Act (CLIA) regulations.

Under CLIA guidelines, laboratories and other medical testing facilities are categorized as waived, or waived testing, moderate, complexity or high complexity. In order for a facility to qualify for waived testing, the facility must only conduct simple tests that have minimal risks of producing erroneous results. Although these facilities might qualify for waived testing, they must apply for and receive a Certificate of Waiver (CW) and pay associated certificate fees. It's also mandatory for facilities which receive waived testing to follow testing procedures and guidelines established by manufacturers whose testing products and/or equipment they use.

To ensure that their workers have the knowledge base and skill to perform testing procedures in accordance with regulations and quality standards, laboratories and other medical facilities that qualify for waived testing could partner with licensed or certified laboratory accreditation organizations to schedule their workers for educational seminars and training courses. Some accreditation organizations offer in-person as well as online training seminars and courses.

Areas of focus in some educational programs include:

Laboratory manager training program
Education proficiency testing program
Quality control training program
Training program to prepare for certification or accreditation surveys

These and other educational programs could prove helpful for waived testing and other medical laboratories, especially if laboratories have received patient or client complaints or citations. Through the training, laboratory directors and staff could discover where weaknesses are at their facilities, including poorly functioning equipment or inexperienced staff members. Over time, these revelations could also help save medical laboratories money as directors at the laboratories repair or replace malfunctioning equipment and continue to provide quality training to their staff.

Mary Rusk is a freelance writer for COLA Central,, a medical accreditation company that provides CLIA Inspection , laboratory accreditation training and testing for medical laboratories. Visit their website today for more information.