AAP News Vol. 13 No. 4 April 1997, p. 22
© 1997 American Academy of Pediatrics
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Eight steps to office lab survival under CLIA regulations

John T. Benjamin M.D., FAAP and Verlin Janzen M.D.

Step One: Decide on the desired test menu.

In setting up an office laboratory, the pediatrician must first determine what test menu is desired: waivered, moderately complex, provider performed microscopy (PPM), or highly complex. Waivered and PPM laboratories do not require inspection, while moderately complex labs do require inspection. More office labs fit into the moderately complex category (40%) than either the waivered (34%) or the PPM (26%), according to the Health Care Financing Administration's (HCFA's) CLIA Update (January 1997). Examples of moderately complex tests include CBCs, most rapid strep tests and mono spot tests. Highly complex labs are generally in hospitals.