A Physician's Guide to CLIA rules

February 18, 2005

Here's what you need to know to keep your office lab functioning smoothly

Okay, so the acronym sounds like a figure out of Greek mythology. But CLIA-or the Clinical Laboratory Improvement Amendments of 1988-is something doctors need to know about, whether they're thinking about starting an in-office lab or upgrading the one they already have.

The idea behind CLIA is fairly straightforward: to ensure the accuracy and timeliness of patient test results, regardless of whether the test is performed in a multimillion dollar off-site lab or in a physician's office. CLIA implementation is the responsibility of the Centers for Medicare & Medicaid Services, which oversees registration, certificates, fees, and compliance surveys.

Offices that do only easy-to-administer, low-risk tests (these include ovulation, blood glucose, dipstick or tablet reagent urinalyses, and rapid strep tests) are "waived" under CLIA and are subject to only minimal requirements; 49 percent of physician office labs are included within this waived category, according to the most recent CMS statistics. Doctors who do more complex testing-such as CBCs, PSAs, routine chemistry panels, and antibiotic susceptibility tests-must adhere to a stricter set of federal requirements, including routine inspections. (For more on starting your own in-office lab, see "Adding a lab: Is it right for you?" June 6, 2003 at http://www.memag.com/memag/article/articleDetail.jsp?id=111424).

Two roads to CLIA compliance The road to CLIA compliance begins with a simple question: Which kind of testing do you intend to do? The two categories are (1) waived tests and provider-performed microscopy procedures (these "PPMPs" include nasal smears for eosinophils, pinworm exams, and fecal leukocyte exams); or (2) moderate- or high-complexity testing. Here are the rules on each:

Waived testing/PPM procedures. If these are the only tests you perform, you're in luck. Compliance with CLIA is relatively painless-you file an application and pay a small fee. (For a complete list of waived tests, go to http://www.cms.hhs.gov/clia/waivetbl.pdf for a list of PPM procedures, go to http://www.cms.hhs.gov/clia/ppmplst.asp.)

• You can download Form CMS-116 from the CMS Web site ( http://www.cms.hhs.gov/clia/cliaapp.asp), along with the instructions for completing the form. Among other things, you'll be asked to identify the type of certificate you're requesting-check off either "Certificate of Waiver" or "PPMP"-and the approximate number of tests you'll be doing per year.

• Send your completed application to the applicable agency in your state. For state agency information, go to http://www.cms.hhs.gov/clia/ssa-map.asp. Some states-California is one-have additional licensure requirements, so be sure to ask your state agency if there are any forms besides the CMS-116 you'll need to complete or any additional requirements you need to meet. Other states-New York and Washington-are exempt under CLIA, which means doctors in them aren't subject to federal rules, although they must still meet state laboratory requirements. Oregon, formerly an exempt state, re-entered the federal program in 2000.

Once your application has been processed, you'll be assigned a CLIA identification number and assessed a biennial fee: $150 for a Certificate of Waiver and $200 for a PPMP certificate.