Waived Testing and Risk Management

What is Waived Testing?
In 1988 the United States deemed that laboratory facilities that perform human testing for the purposes of heath assessment as well as the prevention, diagnosis, and treatment of disease shall be regulated under the Clinical Laboratory Improvement Amendments (CLIA). These regulations clearly defined the parameters of waived testing which includes FDA approved home use tests previously approved under CLIA criteria.

Despite CLIA requirements stating the waived tests must be low risk and simple, waived testing is not error free. Errors arise for a multitude of reasons included not following manufacturer instructions and unfamiliarity with the testing process. Some waived tests have a tremendous potential for serious health risks when incorrectly performed. For instance, waived testing can result in medication adjustments that can prove harmful or even fatal.

Health care organizations, regardless of size or type, witness enormous risk management issues when dealing with waived testing. While rrnisk management protects employees, employers, and clients from loss or injury to high risk practices or procedures even low risk policies like waived testing can result in litigation. In health care institutions risk management is often handled by a committee of physicians, registered nurses, administration, and attorneys with the occasional microbiologist or specialist. Their job is to develop procedures and policies that protect the institution from liability and litigation.

In a strange way risk management and waived testing go hand-in-hand facing concerns regarding the chance of injury (i.e. bloodborne pathogen exposure) for the health care worker as well as practices that may place the health care worker at risk for litigation. The collection of blood specimens is inherently risky; however, the potential exposure to HIV or hepatitis is predominant. Guidelines can be drafted and implemented to minimize blood specimen collection risks as well as specific training that will help protect health care workers from exposure and policies can be placed in the event that exposure should occur.

While there are governmental standards concerning waived testing, individual institutions can maintain policies to further regulate this type of testing thereby limiting risk as much as possible. Guidelines set for the by OSHA, CLIA, CAP, and JCAHO can assist health care institutions in refining their risk management policies and procedures.