Waived Testing - What is That??
"Waived" tests are defined by the FDA as tests that are simple to use with a low risk for error. Certain waived tests such as glucose, dipstick urinalysis and fecal occult blood may be performed in a physician's office lab as long as a Clinical Laboratory Improvement Amendments Certificate of Waiver (CW) is on file, certificate fees are paid and the manufacturers' test instructions are followed explicitly.
Waived laboratories (CW sites) perform waived tests exclusively and, unlike labs that perform moderate or high complexity tests, are not subject to regular inspections, personnel requirements or proficiency testing. You must attach the modifier QW to the CPT code when billing for a waived test.
Consider these points before introducing waived testing or offering a new waived test:
Management responsibility for testing - Who will be responsible and accountable for testing oversight at the CW site, and does this person have the appropriate training for making decisions on testing?
Regulatory requirements - What federal, state and local regulations apply to testing, and is the site adequately prepared to comply with all regulations?
Safety - Does the CW site comply with Occupational Safety and Health Administration (OSHA) standards, including the Bloodborne Pathogens Standard?
Testing space and facilities - What are the physical and environmental requirements for testing?
Benefits and costs - How will patient care provided in the CW site be improved by introduction of the new test and what will it cost?
Staffing - How will introduction of testing affect the current work flow? Are there sufficient personnel to conduct testing? How will they be trained and how will they ensure testing competency?
Documents and records - What written documentation will be needed and how will records be maintained?
For more information regarding the waived testing category, contact ACP's CLIA Specialist at (800) 338-2746. Members may download free of charge the PMC brochures "Waived Testing: Doing It Right" and "Office Laboratory Check-Up."
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