As we face day three of the federal government shutdown, we are hearing more about the deeply felt impact on our federal partners. While we can be grateful that local and state public health agencies are still hard at work, the federal portion of the continuum is minimally staffed and operating a bare-minimum of essential programs that ensure the public’s health and safety. Below are some of the negative effects we are hearing from the Centers for Disease Control and Prevention (CDC), the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS).
Reference Testing Services Will be Delayed or Absent
CDC provides highly specialized reference testing for rare pathogens and for rare instances of drug resistance. Although CDC will maintain many of these services, the number of staff performing these tests will be greatly reduced. The result will be a delay in delivery of potentially lifesaving test results.
For example, the Division of Tuberculosis Elimination performs sequencing to detect mutations associated with drug resistance to rapidly identify persons with drug resistant TB. It is the only laboratory in the country that is currently utilizes this method (which provides a high level of detail) for public health investigations. Delayed results will lead to delays in delivering optimal treatment to patients and mounting an appropriate public health response.
National Disease Surveillance Will Be Weakened
CDC collects data on infectious diseases from all 50 states, local jurisdictions and territories. The compiled data tracks how diseases are spreading and helps scientists to identify multi-state outbreaks. One of the best examples of this function is influenza surveillance. Flu season is upon us; CDC monitors the flu virus strains that are circulating nationally, keeps track of any resistance to drugs, and determines how well this season’s flu shot will work against circulating strains, and sends national alerts to public health professionals when things look out of the ordinary. It shares the data generated from this activity with state and local health departments, providing them with a “big picture” view of flu activity across the country. Armed with this information, they can prepare effectively for potential outbreaks in their area. But a prolonged government shutdown will reduce the clarity of the big picture view, since less data will be collected.
CDC Support of Local Outbreak Response will be Limited
CDC services like advanced testing and consultation to state and local public health programs facing cases or outbreaks of relatively rare diseases. Because these diseases are so rare, many jurisdictions rely heavily on subject matter expertise at CDC for advice and information when responding. Although CDC’s skeleton crew of staff will do its best to assist, state and local public health departments will be largely on their own when it comes to responding to outbreaks of relatively rare diseases like measles or mumps.
Food Safety Will be Negatively Impacted – More People Could Get Sick
- If you and others who ate the same food become ill from certain types of foodborne bacteria, you may never know the cause of your illness, as CDC will not be analyzing all of the data submitted, and FDA and USDA will not be following up on those leads to track the source of the illness. These are necessary steps to ensuring fewer people get sick.
- CDC will delay assessing the proficiency of state and local laboratories that participate in PulseNet. This bi-annual assessment may be pushed back for several weeks, even if the shutdown only lasts several days.
- State and local scientists who want to begin submitting DNA fingerprints to PulseNet will not be allowed to, as CDC certification of new PulseNet participants will be on hold.
- In normal operating status, state and local food regulators do not have enough resources to properly inspect all retail food establishments and restaurants. With federal inspection personnel on furlough, even fewer establishments will be inspected to make sure that they are following the regulations.
- CDC’s IT staff have been furloughed. PulseNet IT staff are not present to aid public health laboratories if they are unable to connect or submit data to the national databases. If the system fails, national outbreak detection could come to a halt. If communication list-serves fail, there are few remaining staff with the know-how to repair these critical national communication tools.
Select Agent Program Has a Delayed Response
Due to the absence of either an FY 2014 appropriation or a Continuing Resolution for HHS and USDA, the Federal Select Agent Program, which oversees the possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products, is not fully staffed and thus unable to provide timely regulatory compliance support to state and local entities. These regulatory gaps could have serious implications for safety and security.
Laboratory Response Network Anticipates Delays
Because the CDC is operating with minimal staff throughout, the Laboratory Response Network, which is the nation’s premier system for responding to potential bioterrorism, chemical terrorism and other public health emergencies, is down to just a few staff with anticipated delays in responding to requests for assistance from state and local public health laboratories and no support for daily reagent shipments.
The larger impact is the lack of federal support for state and local public health. While these state and local agencies continue to conduct routine surveillance and monitor the nation’s health, they rely on their federal counterparts to provide the big picture of disease spread, potential releases of biological threats as well as scientific guidance and methodologies to detect novel threats, like the MERS-coronavirus.
Newborn Screening Laboratory Quality Assessment Delayed
Closing CDC has delayed the fourth quarter assessment of newborn screening laboratory quality. If the delay is extended, then these laboratories will not be able to rely on the assistance of CDC to maintain their compliance with Clinical Laboratory Improvement Amendments, the federal law known as CLIA. Newborn screening depends upon high complexity laboratory operations that are governed by the requirements of CLIA, which include an independent external review to provide quality assurance – and is provided by CDC in the case of newborn screening.
The shutdown will force newborn screening laboratories to seek out non-traditional sources for external review, establish a working relationship with them – possibly at some expense, and pursue activities to meet the CLIA quality assurance requirements. This will not only be inefficient, cumbersome and potentially costly, it will also result in a greater degree of uncertainty because it has never been done.
As CDC’s website details, “The Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences, operates the Newborn Screening Quality Assurance Program (NSQAP). NSQAP is a voluntary, non-regulatory program to help state health departments and their laboratories maintain and enhance the quality of test results. The program is operated in partnership with APHL. The program provides services to more than 85 domestic newborn screening laboratories, 31 manufacturers of diagnostic products, and laboratories in 67 countries. NSQAP has been the only comprehensive source of essential quality assurance services for dried-blood spot testing for more than 33 years.”
The shutdown will add an unnecessary burden and additional complexity to one of the most successful public health programs in the United States.