In the quest to achieve regulatory adherence, more and more hospitals are looking for ways to ensure requirements are integrated into the everyday workflow. CLIA, or the Clinical Laboratory Improvement Amendments, is no exception. The responsibility of three federal agencies, CLIA is a set of requirements used to regulate all laboratory testing on human samples. Moreover, it requires clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
So, why is having CLIA available at your fingertips vital to your operations? Well. CLIA is the responsibility of three federal agencies, namely the CMS, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). The CMS is responsible for issuing laboratory certificates, collecting user fees, conducting inspections and enforcing compliance to the regulations, among other things. The FDA categorizes laboratory tests based on how complex they are, reviews requests for Waiver by Application, and develops the rules/guidance for CLIA complexity categorization. Among the responsibilities of the CDC regarding CLIA, are providing analysis, research, and technical assistance; conducting laboratory quality improvement studies, and monitoring proficiency testing practices.
Having these vital requirements integrated into a system, such as a policy and procedure management software, can be a tremendous asset to your organization’s compliance initiatives. Especially if your system has robust search functionality that can help pull up the information you need as quickly as possible. Doing so not only helps ensure compliance standards are met, but also increases productivity by simplifying staff workload.
To whom does CLIA apply?
CLIA certification is required by all laboratories that are performing diagnostic tests on human samples. All clinical laboratories must be certified in order to receive Medicare and Medicaid payments. Additionally, Alternative Testing or Non-Traditional Laboratory Testing such as Live Blood Cell Analysis (LBA), Biological Terrain Assessment (BTA), thromboelastograph, dental sensitivity testing, and cytotoxic testing, are subject to CLIA requirements.
If you are performing testing on human samples for diagnosis, prevention or treatment of disease or health problems, you are subject to CLIA regulations. This means that physicians who operate their own in-office laboratories are also included whether or not they are billing Medicare. However, if you are only performing simple tests, such as dipstick urinalysis or fecal occult blood, you may be exempt from almost all CLIA requirements and only be required to apply for a certificate of waiver every two years, as long as you strictly comply with the manufacturer’s instructions for the tests, as these tests fall into a ‘waived’ category. Waived tests are defined as simple tests with a small chance of error or risk. According to the CMS, approximately 254,000 laboratory entities are covered by CLIA.
Regulations and Standards Manager
If you’re currently use PolicyManager, you’ll be glad to learn that we’ve integrated CLIA in to our Regulations & Standards Manager. This optional add-on module in PolicyManager, is an unique proprietary component of the software that enables healthcare organizations to crosswalk their policies and procedures to accreditation agencies such as The Joint Commission, HFAP, DNV, CMS CoPs, and others. PolicyMedical is the only policy management software vendor to have a partnership with The Joint Commission, HFAP and DNV.
To learn more about Regulations and Standards Manager, contact us today!