CMS to intensify scrutiny of waived office labs. ('Not an Enforcement Effort').

Many simple lab tests done in physicians' office labs are not being performed properly, and the Centers for Medicare and Medicaid Services wants to change that.

In response to this finding, seen in pilot studies conducted in 10 states, CMS will conduct on-site visits to approximately 2% of all waived labs each year. There are 91,518 such "waived" labs in the United States, and 44,111 of them are physician office labs.

"This is an educational approach, not an enforcement effort," a CMS spokeswoman told this newspaper. "We want to find out what the deficiencies are and help the labs come into compliance."

All laboratories that examine materials derived from the human body for diagnosis, prevention, or treatment purposes must comply with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Labs that perform only tests designated as "simple" by the Food and Drug Administration or Centers for Disease Control and Prevention may be exempted from CLIA by getting a certificate of waiver from CMS.

The number of tests that waived labs can perform has expanded in recent years. The large numbers of waived labs with no oversight, plus serious findings in complaint investigations of these labs, prompted Ohio and Colorado to conduct on-site inspections in a random sample of labs.

Quality and certification problems were found in more than 50% of the labs. Based on this information, CMS expanded the pilot study to include eight more states, and conducted its own compliance inspections in 2000-2001.

The agency found that 32% of waived labs did not have manufacturer's test instructions on hand, 32% didn't perform required quality controls, and 16% failed to follow manufacturer's instructions. At 20% of the labs, blood cards and urine dipsticks were cut in half ...