October 16, 2010

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October 16, 2010

Bio Threats, Bio Terror and Bio Error





Biological threats are found in two of the three looming threats to the nation: Evolving Infectious Diseases and More Frequent and Robust Natural Disasters and Terrorism.
 
It would seem logical that any of the nation's 18 economic sectors would find it useful to exploit the dual benefits associated with mitigation of common vulnerabilities. An effort to minimize the hazards of influenza threats would also provide protection from terrorist-related biological attacks and bolster defenses against self-inflicted bio-errors. These actions could also become a bulwark against hazards identified in past national disasters, lost biological and radiological materials and the potential for terrorists to leverage the chaos associated with these events to introduce their own biological agents.
 
Generic lectures about the history of bioterrorism always begin shortly after the “Garden of Eden Era” and end “yesterday”. They are informative and do provide a statement about “man's inhumanity to man” as do tales of the great plagues, which have proven to be efficient population control events. The 20th Century gave rise to nation-states’ efforts to harness the destructive power of nature as an instrument of war.
 
Observations chronicled in the Federal Defense Administration, Annual Report for 1952 are as relevant today as they were then. (RR No. 149112, 1952).
 
“1. A well-Informed Public........Much remains to be done to increase substantially public awareness ..other major weapons of modern war now known to be in the hands of our enemies. There is far from adequate public preparedness against the threat of biological ...warfare.”
 
Fast forward to the end of the “Hot-Cold War” to the non-nation state threat characterized by the fear that these dreaded Weapons of Mass Destruction (WMD) would fall into the hands of Terrorists. Responding to this threat, President Reagan issued Executive Order 12656, in November 1988. Federal Agencies were tasked to develop comprehensive plans to respond to the many permutations these threats posed.( Federal Register Vol. 53. No. 228, Wednesday, November 23, 1988).
 
The 2001 Anthrax event evidenced little Public Health and Healthcare preparedness for bio terrorism. The public reaction mirrored behavior seen in the earlier Saran attack in Japan. Worried-well “patients” stormed healthcare facilities seeking treatment for their imagined condition only to find supplies of life-saving medicine were exhausted. 
 
 The event did energized the sector to look at “lessons learned” and produced a plethora of Congressional guidance mandating the federal healthcare sector to better prepare and suggesting that their non-federal healthcare counterpart follow their lead on a voluntary basis.
 
An initial weak and underfunded Health Affairs component of the new Department of Homeland Security combined with a lackluster hand-off of major functions to the Department of Health and Human Services and an apathetic non-federal healthcare sector has placed future efforts to catch-up at serious risk. Known as the “weakest link in the Homeland Security chain” this sector is likely to retain that dubious distinction in the foreseeable future.
 
 There is an abundance of guidance to the public health and healthcare sector through generalized and specific Homeland Security Presidential Directives (HSPDs). The specific HSPDs below are designed to mitigate risks, prepare for and respond to threats associated with Infectious disease and Bio-Terrorism:
 
·       HSPD – 5: Management of Domestic Incidents. Enhances the ability of the United States to manage domestic incidents by establishing a single, comprehensive national incident management system.
 
·       HSPD – 7: Critical Infrastructure Identification, Prioritization, and Protection. Establishes a national policy for federal departments and agencies to identify and prioritize United States critical infrastructure and key resources and to protect them from terrorist attacks.
 
·       HSPD – 8: National Preparedness. Identifies steps for improved coordination in response to incidents. This directive describes the way federal departments and agencies will prepare for such a response, including prevention activities during the early stages of a terrorism incident. This directive is a companion to HSPD-5.
 
·       HSPD – 8 Annex 1: National Planning. Further enhances the preparedness of the United States by formally establishing a standard and comprehensive approach to national planning.
 
·       HSPD – 9: Defense of United States Agriculture and Food. Establishes a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies.
 
·       HSPD – 10: Biodefense for the 21st Century. Provides a comprehensive framework for our nation's biodefense.
 
·       HSPD – 18: Medical Countermeasures against Weapons of Mass Destruction. Establishes policy guidelines to draw upon the considerable potential of the scientific community in the public and private sectors to address medical countermeasure requirements relating to CBRN threats.
 
·       HSPD – 19: Combating Terrorist Use of Explosives in the United States. Establishes a national policy, and calls for the development of a national strategy and implementation plan, on the prevention and detection of, protection against, and response to terrorist use of explosives in the United States.
 
·       HSPD – 21: Public Health and Medical Preparedness. Establishes a national strategy that will enable a level of public health and medical preparedness sufficient to address a range of possible disasters.
 
The non-federal healthcare sector owns or controls upwards to ninety (90%) percent of the available healthcare resources needed in times of national disasters. If the public and private sectors do not become full partners in the Nation Response Framework (NRF), the country remains at great risk. An important component to of that readiness posture is a meaningful adoption of the National Incident Management System (NIMS). Self-reporting on preparedness levels for NIMS leaves a lot to be desired and poses a soft underbelly waiting to be exploited by nature or man-made threats. Lack of effective oversight at all levels multiplies the danger exponentially.
 
Healthcare industry stakeholders, particularly individuals and groups who are in the hospital workforce have been critical of the level of attention given to prepare for all-hazards in general and pandemics in particular. The Institute of Medicine (IOM) report, September, 2007 surfaced considerable concern about healthcare preparedness for a possible Pandemic Flu.  
Early in April 2009, weeks preceding the announcement of the first wave of H1N1 Flu, the results of a study sponsored by members of healthcare unions was released. The study found that little had been done to follow the IOM recommendations and that a majority of the surveyed healthcare facilities were not prepared to provide a safe and secure workplace in the event of a pandemic.
 
These reports reflect the persistent themes that Congressional oversight of Federal Agencies responsible for the safety and security of all elements of the healthcare industry is poor. Accreditation and Certifications from these Agencies have little reliability when it comes to all-hazards protection.
 
 
Years of planning initiatives and Billions spent on preparedness for Pandemic Flu had limited effect on the nation's readiness to deal with H1N1 (Novel Flu) spreading from Central Mexico to multiple areas in the United States before it was identified and effective cross-border defensive strategy could be activated. Lack of robust border security and an immature surveillance tracking system made for a weak response.



The second wave of H1N1 Flu caught the Public Health and Healthcare Community completely        flatfooted. Contrary tooptimistic announcement on H1N1 readiness (“H1N1 preparedness is going well”) from the White House, experts have identified serious gaps in preparedness in general and for special populations in particular.
 
Infants and children are much more vulnerable to exposures to evolving infectious diseases. There is a cruel irony in the fact that this nation’s Public Policy celebrates robust themes such as “no child left behind” and “every child must have access to quality health care” but fails to promote a reasonable level of protection for them during natural and man-made disasters.
 
If past is prologue, hospitals and other healthcare sites serve as beacons of safety and hope during known or perceived calamities such as an H1N1 pandemic. Parents of children with known special needs and illnesses will seek treatment and comfort from their traditional tertiary/specialty facilities. These facilities will be overwhelmed with traditional specialty needs patients and other infected children and they will have little expansion capacity for treatment of any of these populations.
 
To make things even more challenging,the “just in time” supply chain takes on a high profile during natural and man-made disasters. Location and distribution of life-saving equipment and supplies takes on a life of its own. The brief 9/11 anthrax scare in the nation’s capital resulted in hospitals having to “lockdown” with angry local mobs accusing the hospitals and their staff of hoarding limited supplies of life-saving drugs. Relief supplies on their way to a devastated New Orleans after Katrina were hijacked by roving mobs.
 
General acute care hospitals do not serve large pediatric populations and do not have staff credentialed or trained in pediatrics. The community-based facilities also have limited supplies of critical resources such as pharmaceuticals in pediatric dosages, and appropriately sized equipment e.g. mechanical ventilators and other respiratory equipment (ambu masks).
 
Federal H1N1 Flu treatment priority policies abound. According to all accounts they are driven by groups of selected, well intentioned, experts within multiple governmental and academic domains. Many times these groups have limited experience, “up-close and personal” exposure, to these situations and fail to consider important unintended consequences of their guidance. This tendency to promote “one size fits all” guidance through “stove pipe” communications create confusion and chaos at the “hands- on” levels of response.
 
 For example in Ohio, prisoners were prioritized to receive H1N1 vaccine ahead of local school systems.
 
As observed in the GAO reports, guidance generated at state and local levels also lacks consistency and clarity. Many state legislative bodies have not removed material barriers (moral, ethical and legal) which hamstring realistic, effective planning and response for pandemic mass treatment events.
 
 For example, in many states when healthcare workers or volunteers are not afforded legal liability protection and there are legal prohibitions against the acceptance of a lower standard of care during emergencies.
 
Responding to these calamities is difficult at best and more often than not responders are faced with limited supplies of life-saving medicines and equipment. They are faced with the bewildering range of decisions which are unique to their geographic locations. Two governmental levels (Federal and State) of populations are often overlooked by community and hospital organizations: Prison Populations.
 
The limitations on the scope and capacity of healthcare within prison systems pose a potential lethal follow-on waves of H1N1 Flu place local communities at risk. The potential for “multiplier spillover effect,” via movement of inmates out of confinement into local healthcare facilities, is a reality. Most hospitals located in vicinities of confinement facilities have contractual arrangements for the provision of healthcare which exceed prison/jail capabilities. They also have commitments to respond to inmate casualties during any number of all-hazards events. Pre and post 1st wave of H1N1 flu, national surveys of hospital preparedness and a plethora of public press and scholarly publication indicate that the Public Health and Healthcare sector is ill prepared to meet the needs of such an event.
 
The DHHS has initiated an action to identify the number and location of mechanical ventilators within the country (this information will not be available to the public). Earlier studies indicated that 70-80% of existing mechanical ventilators are currently already allocated to patients. Some models estimate that in a severe pandemic the nation would need 750,000 mechanical ventilators; the last-published availability estimates indicated that there were a total of 110,000 nation-wide. How these will be allocated in a crisis is a fundamental issue that remains to be clarified. The New York Legislative body made a noble attempt (see report) to address this, however it is not clear whether grandma’s ventilator would be re-allocated to a sixteen year old incarcerated juvenile – who falls into the new priority cohort.
 
 
And now we have new concern for an old threat: Bioterrorism. Post 9/11, threat of non-state terrorists using an almost endless list of biologic agents has enjoyed a very high profile. The new Graham/Talent report posits that the national attention to preparedness for bioterrorism has lost its vigor. We have, for years, expressed our disappointment with the national movement away from bioterrorism preparedness to pandemic flu. The lost opportunity to achieve the dual benefits of being prepared for bioterrorism and creating a solid defense against all evolving infectious diseases is incalculable.
 
We do not minimize the recent H1N1 threat but simply want to point out that the threat we faced in 2009 provided us with a substantial lead-time to prepare. We know the cyclical nature of the disease and have observed its seasonal impact on the southern hemisphere. Many are disturbed with the nation’s response to a known agent and what appears to be a breakdown in our ability to cope with and record the events as they transpire.
 
Serious problems with the reliability of availability of H1N1 tests; false Positive findings are disruptive and may lead to overly cautious care while false Negative findings result in inadequate treatment and greater exposure to the public. This type of failure on government's part to protect the public has resulted in a loss of confidence in the system.
 
Unexpected biological agents introduced intentionally or by accident (BioTerror/BioError) into the environment are fraught with unimagined consequences. 
 
As described in the GAO 09 574 Report, some speculate that the greatest national biological danger comes from the unbridled proliferation of bio-laboratories across the country. Along with the host of new bio-labs are an estimated 15,000 individuals working with these deadly agents. Proper vetting of these employees is a challenge and gaps in disciplined background searches create a substantial “insider threat”. 
 
Recent Senate hearings on the lack of security and cavalier manner in which the bio-lab community has responded to known threats is scandalous. Senator Susan Collins was clearly disturbed over a recent DHS OIG report which identified gaps in site security.
 
The introduction of any number of the world’s most dangerous bio-agents from these labs into the environment by accident or intent would be nightmarish. Within a hospital setting, already challenged by “healthcare acquired infections”, this would be devastating. Depending on the bio-agent, the transmission period could be days or weeks before it was identified. It takes little imagination to visualize the extent of contamination and the cost in lives. 
 
The specter of a uniformed maintenance person with fabricated identity card (from an outsourced maintenance group) showing up at the hospital in the middle of the night to fix a disabled air conditioning unit, who may have among other items in his toolkit a couple of cylinders of “weaponized bio-agent,” is thought provoking...
 
The stark failures in preparedness to protect a trusting public from known threats comes from all quarters of Federal government. State and Local governments. Public health and healthcare sectors have turned a blind eye to evidence-based information on existing hazards while healthcare professional and trade organizations joined the collective apathy and denial.
 
Some of their advisers posit the theme,if I do my best and create a strong plan, it may become a legal risk against me so it is best to hunker down and let events unfold, that may be the best legal protection available to me” stated one legal expert. The press release “Hospital CEOs say bioterrorism plan are in place,” from Chicago March 13, 2003, by the American College of Healthcare Executives (ACHE), may have been premature.
 
FamilySecurityMatters.org Contributor Dr. James Blair, DPA, MHA, FACHE, FABCHS, is president and CEO of the Center for HealthCare Emergency Readiness. This article was adapted from excerpts from Blair's book, Unready: To Err is Human: The Other Neglected Side of Hospital Safety and Security, which was published in June. He is also a career-retired army colonel with 28 years of active service. Among his private sector experiences, he served as VP of Hospital Corporation of America, Middle East Limited and as an independent consultant to Joint Commission International.
 
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