We still sometimes see organizations (both psychiatric hospitals and behavioral health organizations) receiving TJC survey findings related to waived testing. So, this month, we are recapping the 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:
- They employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible
- They pose no reasonable risk of harm to the patient if the test is performed incorrectly
- They 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 BH 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 (See Note below.)
- Instrument maintenance
- Quality control checks
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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 waived 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 per manufacturer’s instructions. (Prior to 2012, testing was required each day the instrument was used. In 2012, the requirement was changed to be “per manufacturer’s instructions”.)
- For instrument-based waived testing, quality control checks must include two levels of control, if commercially available.
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- 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 test strips and the control solution should be labeled (once they are opened) with the date when they should be discarded. This date should not exceed the timeframe that the manufacturer recommends. Often, this is 90 days but, again, it should be whatever the manufacturer recommends. This information is typically contained in the manufacturer’s insert.
Is Breathalyzer testing a waived test?
No, it is not. This was recently confirmed by a Laboratory Specialist at a TJC Behavioral Health Conference. It was explained that this is the case because laboratory tests are in vitro testing; i.e. the testing of material that has been removed from the body. In the case of Breathalyzer testing, no material has been removed from the body.
What types of RFIs do organizations get for waived testing?
The most commonly cited issues on surveys are the following:
- Only one method (instead of two) used to evaluate staff competency
- Quality control checks using only one level of control
- Control solution for glucometers not dated when opened
- Control solution for glucometers used beyond discard date
- No confirmatory testing in the policy for glucose testing.
- No written policies/procedures for waived testing
- BH organizations: not having a CLIA certificate (which can result in Contingent Accreditation)
Do the Waived Testing standards apply when patients/clients are using their own glucometers?
No, the Waived Testing standards only apply when organization’s 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, refer to CMS’s Tests Granted Waived Status Under CLIA (PDF, 475KB).