Posts Tagged urine dipsticks

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Guest Lab Consultant Libby Knollmeyer: The Pros and Cons of Moving from a Waived Medical Lab to a Non-Waived (Certificate of Compliance) Lab

Many physicians have some type of lab testing capability in their practices, with most practice labs classified as Waived Labs, which means having a Certificate of Waiver.  This Certificate enables a practice to perform simple tests including tests such as urine dipsticks, rapid Strep A for sore throats, Mono Tests, pregnancy slide tests on urine, and Rapid Flu tests.

There is little effort required to become or maintain a Waived Lab

There are no personnel qualification requirements, and the only regulation is to “follow the manufacturer’s instructions” on the test packages. In order to obtain a Certificate of Waiver, an application form (the CMS116 form) must be completed and submitted to CLIA at the state CLIA office.  The CLIA office will issue a CLIA identification number and the practice will receive a bill for the Certificate of Waiver for $150.  Life is wonderfully simple at a Certificate of Waiver level.

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Posted in: Compliance, Day-to-Day Operations, Medicare & Reimbursement

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Guest Consultant Libby Knollmeyer: “I think I want a lab for my office!”

While there are multiple levels of laboratory complexity, it is possible to have a lab in your practice with very little fuss and administrative burden.  The level of complexity of any lab is determined by the testing being performed, and the complexity level of each test or test system is assigned by the FDA.

What is Waived Testing?

The Waived category allows physicians to do simple testing in their offices to facilitate diagnosis and enhance patient care with on-the-spot results.  A test or test kit gets classified as Waived if it:

  • is extremely easy to perform
  • has built-in safeguards, and
  • requires little education or training to do and interpret correctly.

Urine dipsticks, rapid Strep A kits, urine pregnancy test kits, and rapid Mono Test kits are examples of waived tests.  In addition, there are also some Point of Care (POC or POCT) tests/instruments that have been granted waived status, including glucose monitors and hemoglobin instruments.  There is a wide variety of testing available to the practitioner without having to bear the administrative burdens of the moderate or high complexity laboratory.

Of the various types of laboratories defined, the Waived lab has the least regulatory oversight. CLIA does not have personnel requirements for Waived labs other than requiring there be a lab director, which any  physician in the practice can fulfill. It is common for the lab director to receive a monthly stipend of $300 – $500 per month for fulfilling this simple role.

The only regulations that apply to waived testing are:

  • requirement to have a CLIA ID # and pay the Certificate Fee every two years, and
  • to follow the manufacturer’s instructions for any test performed.

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Posted in: Day-to-Day Operations

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