US CMS lacks med labs oversight capacity

9 July 2006

The US Government Accountability Office has found that the Centers for Medicare and Medicaid Services (CMS) lacks the capacity to effectively provide oversight of laboratories that conduct clinical testing. Widespread variations in the standards offered by private agencies contracted to provide accreditation on behalf of the CMS are to blame, according to the GAO.

Under a 1988 law, the CMS is required to ensure that laboratories are tested in basic proficiencies at least four times per year. However, the case of Baltimore's Maryland General Hospital, which was cited by the agency last year, brought to light a situation where "insufficient data exist to identify the extent of serious quality problems at labs," according to GAO investigators.

Although the CMS claimed that its failure to meet its obligations was the result of a lack of resources, the GAO found that the agency had spent $70.0 million less than the program's budget provided for from 1998 to 2004. During that time, sanctions were proposed for 9,000 laboratories, but only enforced in 501 cases. For repeat offenders, the proportion of enforcement was a feeble 30 of 274, barely one in nine cases.

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