GAO says CMS needle safety inspections must continue

January 12th, 2015

Citing the risk of continuing hepatitis outbreaks, the U.S. Government Accountability Office (GAO) recommends that the Centers for Medicare & Medicaid Services (CMS) resume inspections of injection safety in ambulatory care centers. Formed in the wake of recurrent outbreaks due to improper and unsafe practices with needles and vials, the CMS inspection program lapsed at the end of fiscal year 2011, the GAO reported.

“Without some form of continued collection and analysis of injection safety data, CMS will lose its capacity to oversee how well surveyors monitor unsafe injection practices, and CDC will be unable to determine the extent of these practices,” the GAO warned. “However, in part because of concerns that collecting these data is a burden to surveyors, CMS officials said the agency stopped collecting data from surveyor worksheets after fiscal year 2011.”

The Department of Health and Human Services (HHS) is expected to resume the inspections in light of the report, which was presented to a Congressional committee.

Data on the extent and cost of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings are limited and "likely underestimate the full extent of such outbreaks," the GAO found. The CMS has expanded its oversight of unsafe injection practices in ambulatory care since 2009 by requiring surveyors who inspect these facilities to use its Infection Control Surveyor Worksheet. In addition, safe injection practices are included under several of CMS’s broader health and safety standards that also address a number of other topics related to infection control and medication administration. As part of implementing the expanded oversight of ASCs, CMS collected and plans to analyze detailed information from these surveyor worksheets for fiscal years 2010 and 2011. This information will be used to assess CMS’s oversight efforts to improve infection control and also allow CDC—with which CMS shared its data—to determine a baseline assessment of the extent of unsafe injection practices in ASCs nationally.

The GAO recommended that HHS:

• Resume collecting data on unsafe injection practices that will permit continued monitoring of such practices
• Use those data for continued monitoring of ASCs
• Strengthen the targeting efforts of the "One and Only Campaign" for health care settings not overseen by CMS.