Industry News: Understanding CLIA Waived Testing And How It Can Help You
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Non-legal and non-medical practitioners may find it challenging to understand the jargon that describes the concepts of CLIA waived testing and its implications. While many people may be familiar with some home testing kits such as the commonly used devices for blood pressure monitoring and pregnancy testing, few are likely to make the association with federal laws and government agencies that regulate the use of these testing products. Some test devices are covered by what is called CLIA waived testing. Here is a short and simplified guide to understand CLIA regulations and answer some frequently asked questions.
What is CLIA?
The Clinical Laboratory Improved Amendments (CLIA) refer to federal laws and procedures that provide for the supervision and regulation of all clinical laboratories and establish a set of standards to be observed by facilities that perform testing and procedures for non-research purposes. Under CLIA provisions, all clinical laboratories in the United States that perform testing on human specimens – such as tissue, blood, and other body fluids – for the purpose of providing information to be used for the diagnosis, treatment, prevention, prognosis or health assessment of a disease or medical condition are required to comply with the prescribed standards. These labs are also required to secure the proper certificate to operate. Laboratories located in hospitals, medical offices and independent commercial facilities are included in the scope of the law’s coverage. All laboratory personnel are mandated to observe prescribed CLIA standards in conducting clinical examinations and procedures. The standards vary according to the given criteria such as test complexity and potential harm caused to the patient. CLIA defines three categories of test complexities: waived, moderate and high. Laboratories that perform tests of moderate to high complexities are required to be regularly enrolled in proficiency testing programs to ensure that the laboratories are properly equipped to conduct said tests. The more difficult the test category, the more rigorous are the requirements to be complied with. Failure to abide by the appropriate standards will merit the imposition of the relevant sanctions by the enforcement agencies.
Commonly known as CLIA ’88, the legislation was passed by the U.S. Congress in 1988 as an amendment to the Public Health Services Act, to revise the federal program for the certification and supervision of non-research laboratory testing facilities. The final CLIA ’88 regulations were first published in 1992, phased in through 1994, and further amended in 1993, 1995 and 2003, according to the CDC website. The best feature of CLIA ’88 is that it unifies all prior regulations into a single uniform standard, and subjects physician office laboratories to the same parameters. This assures the public and the patients of timely, reliable and accurate test results, wherever the tests are performed. The various aspects of CLIA are implemented and supervised by different agencies. The Centers for Medicare and Medicaid Services (CMS) handles the clinical laboratory oversight functions, while the Centers for Disease Control and Prevention (CDC) manages the scientific consultations aspects. Meanwhile, the Food and Drug Administration (FDA) is in-charge of the test level categorization.
CLIA Waived Testing
As mentioned above, there are three categories of testing: waived, moderate and high. The Food and Drug Administration (FDA) categorizes the test complexity levels according to factors such as amount of interpretations, quality control requirements, degree of independent judgment, difficulty of calculations, examinations and methodologies used, and training required to operate the instruments, as reported in this document.
To be “waived” means that certain tests can be performed without the need for the conduct of more stringent standards imposed by CLIA. The FDA classifies as “waived” those tests that employ relatively simple methodologies such that when performed properly, these tests are least likely to yield erroneous results. Even when performed incorrectly, these tests are least likely to pose danger on the patients.
However, there is no guarantee that all waived test results are completely error-free since mistakes can be committed at any stage of the testing procedure. Erroneous test results can be potentially harmful as when test results determination changes in medication type or dosage. To minimize the risk of erroneous results, the tests must be performed only by properly trained personnel who observe the required clinical standards. In performing these tests, laboratory personnel are mandated to strictly follow the manufacturer’s instructions in order to comply with the quality control requirements imposed for some tests included in the new waived test list.
Laboratories that have applied for and have been duly issued the “Certificate of Waiver” can perform waived tests. While these laboratories or offices are not subjected to rigid inspection policies, they may be inspected at random upon reports of patient complaints. Some of the most popular waived tests include glucose tests, cholesterol tests, some urine tests, some fecal occult blood tests, hemoglobin tests, H. Pylori tests, and home pregnancy tests, among others. Home test kits – including some of our products at Confirm BioSciences – generally fall under the waived test category. The complete list of waived tests, as well as the test categorizations, are published and provided by the Food and Drug Administration.
Benefits and Importance
Having certain tests cleared by the FDA as “waived” means that these are safe to be performed at home or in non-laboratory settings. This makes it easier and less expensive for patients to monitor their medical conditions. For instance, those suffering from diabetes can perform glucose tests through home glucose monitoring systems, while people who have hypertension can track their blood pressure levels through blood pressure home kits. Having access to these handheld devices that are easy to use and that produce accurate results helps to significantly cut down medical costs. Not only can these tests be conveniently performed in the privacy of your own home, but they can also be used in other non-laboratory settings such as community health centers, counseling centers, pharmacies, ambulances, nursing homes, and physicians’ offices. Because laboratories that exclusively perform waived tests are subjected to lesser fees and requirements, they can operate at lower costs and with relatively less-trained health professionals. Also, they are not subjected to as many routine inspections as the other labs that perform more complex tests.
How to Obtain a Certificate of Waiver
A clinical laboratory that offers only waived testing and is not a holder of under any other type of CLIA certificate must first obtain a Certificate of Waiver (CoW) before performing waived testing procedures. The laboratory must complete an application form (CMS Form 116), which may be downloaded from the CMS website or obtained from the local state agency. The completed form must be submitted to the state agency in the same area where the laboratory intends to perform the testing procedures. The appropriate state agency will require and collect payment for registration. Upon receipt of the paid fees by CMS, the certificate will be sent to the laboratory applicant. Only then can the laboratory begin performing testing procedures. A laboratory that is duly issued a CoW is subject to the following additional requirements:
- The laboratory must perform only waived testing.
- In performing these tests, the laboratory personnel must strictly follow the current product manufacturer’s instructions relating to the test procedures. The laboratory must not modify any of the given instructions.
- The facility must allow both scheduled and random on-site inspections to be conducted by CMS representatives.
- The State Agency must be informed of any changes in ownership, name, address or director within thirty (30) days from the time such changes take effect, as specified in this document.
- The CoW must be renewed every two years, with corresponding fees.
The laboratory must likewise comply with local state regulations pertinent to clinical laboratory testing. These regulations may vary across jurisdictions, some of which may be more stringent than those imposed by CLIA. In addition, it must also adhere to the safety standards required by the Occupational Safety and Health Administration (OSHA) relevant to workplace hazards.
Multiple Testing Sites
A laboratory with a duly issued Certificate of Waiver that intends to perform waived testing at more than one site must secure a separate certificate for site where such testing procedures are to be performed, unless it falls under the exceptions provided by CLIA. The laboratories that are exempted from securing individual CoWs for each site are:
- Laboratories that are not located at a fixed area or those that move from one testing site to another, such as health screening fairs and mobile units
- Non-profit, federal, state or local government laboratories that perform a limited number of tests
- Laboratories located at adjoining buildings of the same hospital or the same campus
Following Manufacturer’s Instructions
To ensure accuracy of test results, it is crucial to always follow the current product manufacturer’s instructions without deviation. The instructions can be found in the product insert or label for each test. Some product inserts detail the procedures step-by-step and explain each stage of the test extensively. Others provide a “quick reference” that may present the instructions in diagram formats. Laboratory personnel or home users must read and understand these instructions before performing the test. They should also be sure that the correct specimen and correct testing solutions are used, as specified by the product instructions. Manufacturers may modify their instructions to match any introduced change in their test systems. Those performing the test must use the appropriate set of instructions to arrive at accurate results. When in doubt as to whether the instructions on hand are the current or most recent version, the manufacturer must be contacted. Failure to follow the proper instructions may result in erroneous results, which can have a significant negative impact on the treatment plan, diagnosis, or assessment of a certain health condition. Laboratory personnel and home users are absolutely prohibited from introducing any changes or limitations to the given test instructions. Not only does this result in inaccurate results; more importantly, modifying the test procedures changes the test system’s “intended use” as approved by the FDA. When this happens, the test no longer falls under the waived tests category and performing it will require a separate license or certificate and will subject the laboratory or facility to the other CLIA standards.
Responsibilities of the Laboratory Director
It is incumbent upon the laboratory director to ensure proper observance of good laboratory practices and compliance with testing. The director is tasked to perform the following responsibilities, among others:
- Employ and maintain adequately trained testing personnel who can: handle the specimen as directed, perform the test according to the given instructions, read the test results accurately, and document the test results;
- Supervise laboratory personnel and implement staff evaluation mechanisms;
- Supervise conduct of testing to ensure accurate results;
- Monitor any environmental changes that may affect the quality and integrity of the tests such as changes in temperature, lighting, and others;
- Supervise and monitor procurement of supplies and equipment to ensure that only products of reliable quality are used in the laboratory;
- Comply with CLIA and state-imposed
Medical diagnostic procedures have advanced through the centuries to help health practitioners identify various ailments and treat them accordingly. Technological breakthroughs have also made it possible for non-medical professionals to monitor their own medical conditions. Home test systems are revolutionary and non-traditional in the sense that these devices virtually bring clinical laboratories to the patients in their homes. Their benefits extend beyond convenience for they allow patients to control some aspects of their physical well-being, and the option to live better lives at lower costs.