During 2011, some organizations had challenges in the area of waived testing during their surveys. So, this month, we are recapping the TJC requirements for waived testing and answering some frequently asked questions from our clients.
What exactly does "waived testing" mean?
Waived testing is defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988 as tests which have the following characteristics:
- Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible
- Pose no reasonable risk of harm to the patient if the test is performed incorrectly
- Have been cleared by the FDA for home use.
Thus, these tests are "waived" from certain federal requirements. The most commonly used waived tests in behavioral health settings are glucose testing, urine pregnancy screens, rapid strep screens, and urine drug screens. Any organization that performs waived testing needs a CLIA certificate to do so.
What are the TJC requirements for waived testing?
The TJC standards for waived testing are in the Waived Testing chapter of both the Hospital and Behavioral Health Manuals (WT.01.01.01 -WT.05.01.01.) The standards require the following:
Policies and procedures (WT.01.01.01)
- Which tests will be used
- Procedures for each test
- Need for confirmatory testing (if such testing is required)
- Instrument maintenance
- Quality control checks
Note: For each test, the policy should define whether the test is screening or definitive. A test is considered definitive when a clinical treatment decision or diagnosis is made based on the result. For example, glucose checks done to adjust sliding scale insulin would be considered definitive. A test is considered screening when additional information from testing is required to make a treatment decision or diagnosis. For example, a rapid strep test done but followed up with cultures prior to determining whether to administer antibiotics would be considered screening. If a test is considered screening, the specific criteria for confirmatory testing should be included in the policy/procedure.
Staff Competency (WT.03.01.01)
- Staff must be trained in each waived test they perform; documentation required.
- Competency for each test must be assessed at orientation and annually; documentation required.
- Competency must be assessed using two of the following methods:
- Performance of a test on a blind specimen
- Periodic observation of work by supervisor
- Monitoring of each user's quality control performance
- Written test
Quality Control Checks (WT.04.01.01)
- For instrument-based waived testing, quality control checks must be performed on the instrument each day it us used for patient testing. (Quality control checks are not required on days when the instrument is not used for patient testing.)
- For instrument-based waived testing, quality control checks must include two levels of control, if commercially available.
Notes:
- Tests approved by the FDA for home use only should not be used for professional purposes. For example, glucose meters cleared for home use should not be used in a hospital setting by nursing staff unless they are being used for patient education only.
- For glucometers, both the container of glucose test strips and the control solution should be labeled with the date of opening. Once opened, the test strips within that container and the control solution should not be used beyond the timeframe that the manufacturer recommends (typically 90 days.)
What types of RFIs do organizations get for waived testing?
The most commonly cited issues on survey are the following:
- Quality control checks using only one level of control.
- Containers of glucose test strips not dated when opened.
- Test strips used beyond 90 days after container was opened.
- No confirmatory testing in the policy for glucose testing.
- Only one method (instead of two) used to evaluate staff competency
- No written policies/procedures for waived testing
Do the Waived Testing standards apply when patients/clients are using their own glucometers?
No, the Waived Testing standards only apply when organization staff is administering the waived test. However, if patients/clients are conducting their own waived testing, it is critical to assess that they are competent to do so and that the instrument they are using is operating properly.
For a current list of CLIA approved waived tests click on CLIA Waived Tests List.
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