Waived Lab | Manage My Practice

Guest Lab Consultant Libby Knollmeyer: What to Expect When You’re Expecting (or Not Expecting) a Lab Inspection

Posted by Abraham Whaley on February 8, 2012

Prior to CLIA ’88 (Clinical Laboratory Improvement Amendments of 1988) only laboratories participating in interstate commerce underwent inspections. Since the enactment of CLIA ’88, all laboratories are subject to inspection, and all non-waived laboratories are inspected. CLIA has the right to appear at any point in time to inspect a lab.

There are two types of inspections for non-waived labs: routine and non-routine

Routine inspections take place every two years as mandated by CLIA, regardless of which agency is responsible for the inspection. If a lab has a Certificate of Compliance, CLIA will be the inspecting agency. If the laboratory has opted for a Certificate of Accreditation from one of the approved accrediting agencies, that agency will perform the inspection. Either way, the inspections are set on a two year cycle and the renewal of the laboratory’s certificate is dependent upon successful completion of the inspection. If no deficiencies are cited, the certificate will be renewed very soon after the inspection is completed. If deficiencies are cited during the inspection, the laboratory will receive a deficiency report and will be given a timeline to submit a plan of correction. Once the plan of correction is accepted by the inspecting agency, the certificate will be renewed. Failure to achieve a successful conclusion to the inspection process will result in the cancellation of the lab’s certificate, and therefore loss of privileges to do lab testing and to bill for lab testing.

The inspection cycle differs slightly for a newly set-up laboratory. CLIA or the accrediting agency will come in to do an inspection after the lab has been in operation for 3 – 6 months to ensure everything required is in place and all regulations are being followed. CLIA and the accrediting agencies do not inspect prior to the lab starting testing operations because they want the lab to generate data for them to review upon their inspection.

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

Posted by Mary Pat Whaley on August 14, 2011

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.