Failure to Launch: OIG’s Recommendations to HHS

By Jennifer D. Newberger –

One of the tasks of the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) is to make recommendations that will result in cost savings and/or improvements in program efficiency and effectiveness.  Unfortunately, as we are all too aware, OIG making the recommendations is very different from HHS implementing them. 

This is all too clearly demonstrated by OIG’s March 2011 release of its “Compendium of Unimplemented Recommendations” (“Compendium”).  The following list is a small sampling of recommendations not adopted by HHS:

• Improve States’ and Localities’ Medical Surge Preparedness for Pandemics

Remember anthrax and H1N1?  Given the panic that ensued after these events, it would seem that the states and localities, working with the federal government, would prioritize preparedness.  Yet OIG found that, based on a sample of 5 states and 10 localities, while partnerships had been established to prepare for a medical surge, much improvement is needed in coordination of volunteers, tracking of medical equipment, and planning for alternative care sites.  

• Ensure That State Public Health Laboratories Meet Cooperative Agreement Requirements on Biological Threats

If a biological health threat was coming to your neighborhood, wouldn’t you want your state public health lab to be able to detect and report that threat quickly?  Unfortunately, although the Centers for Disease Control and Prevention (CDC) awarded grants for this purpose in 2006, most state labs fail to meet the requirements of those grants to demonstrate rapid detection and reporting.

• Improve and Strengthen Food Facilities’ Compliance With Records Requirements for Traceability of Food Products

Eggs.  Spinach.  Peanut butter.  We remember the stories.  Just like you want your state lab to identify biological threats quickly, you probably also want FDA to be able to trace food quickly if it has reason to believe the food poses a health threat.  And yet, when OIG tried to trace 40 food products through the supply chain, it was only able to do so with complete success, through the whole food chain, for 5 of those products. 

• Use Adverse Event Reports to Detect and Address Safety Concerns About Medical Devices

The Center for Devices and Radiological Health (CDRH) requires manufacturers and user facilities to submit reports of adverse events within certain time frames.  However, OIG found that CDRH rarely reacts when these entities submit late reports, doesn’t document any follow-up on adverse event reporting, and rarely performs its own first read of adverse events on time.  Additionally, the information contained in the reports is often incomplete and not helpful to the reader. 

• Strengthen Inspections of Domestic Food Facilities to Ensure Food Safety and Compliance

OIG found that many food facilities go 5 years or longer without an FDA inspection.  When FDA does inspect, and does find violations, they often don’t act quickly enough to prevent future health risks. 

We all know HHS has a lot to manage.  But it might want to prioritize areas identified by OIG to save costs and improve effectiveness and efficiency.  It seems hard to argue the benefits of those goals.