What is a Waived Test?
Clinical Laboratory Improvement Amendments 1988 (CLIA ‘88) establishes quality standards for all laboratory testing to provide accuracy, reliability and timeliness of patient test results regardless of where the test was performed. As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” By the CLIA regulations, certificate of waiver laboratories perform only tests that are determined by FDA or CDC.
The most commonly performed CLIA waived tests are geared to monitoring chronic conditions such as diabetes and heart disease. The most commonly performed waived tests in physician’s office are:, waived chemistry panels, cholesterol and lipid panel, prothrombin time (PT/INR), urinalysis, diabetes monitoring and A1c testing*
*Source: Physician office laboratory markets, Kalorama Information, Table 5-3, bases on CMS data, November, 2010, HIDA Physician Report,
The certificate of waiver laboratories must meet the following requirements under CLIA:
- Enroll in the CLIA program;
- Pay applicable certificate fees biennially; and
- Follow manufacturers’ test instructions.
To Begin a Waived Testing Program in your practice:
- Apply for a CLIA Certificate of Waiver using form, CMS-116
- Submit CMS-116, plus any state specific paperwork, to your practices local state agency
- Pay any applicable fees to Center for Medicare & Medicaid Services (CMS)
For a list of waived tests sorted by the test categorization date and by the test system name, visit the FDA website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm.
Best Practices for Performing Waived Tests
- Keep the manufacturer's current product insert and instructions for the laboratory test in use and be sure it is available to the testing personnel for reference.
- Follow the manufacturer's instructions for specimen collection and handling.
Create a procedure manual to ensure personnel understand and follow instructions for performing tests.
Properly identify the patient.
- A) Are specimens stored at the proper temperature?
- B) Are the appropriate collection containers used?
Be sure to label the patient's specimen for testing with an identifier unique to each patient.
Inform the patient of any test preparation such as fasting, clean catch urines, etc.
Read and understand the manufacturer's product insert and instructions prior to performing a test.
- A) Does the name on the test requisition (or prescription) match the patient's name?
- B) Does the name on the patient's chart match the name on the patient's identification?
Follow the storage requirements for the test kit and be certain to not mix component of different kits
Record the patients' test results in the patient record, such as the patient's chart, laboratory test log or electronic health record.
- A) Become familiar with the test procedure and perform each step in the proper order.
- B) Know the time required for performing the test and achieving the optimal result.
- C) Prepare to have all of the required reagents and equipment ready before performing the test.
- D) Be able to recognize when the test is finished
- E) Follow the manufacturer's instructions for all steps in the testing process including specimen
collection and handling and performing quality controls.
Perform any instrument maintenance as directed by the manufacturer.
- A) Record the results according to the instructions in the manufacturer's product insert.
- B) If it's a qualitative test, spell out positive/negative or pos/neg as symbolic representations can be altered.
- C) Include the name of the test, the date the test was performed, and the initials of the testing
personnel in the test record. Include the calendar year in the date.
- D) If the same test is performed on a patient multiple times in one day, include the time of each test.