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09.09

Interoperability and U.S. Preparations for 2009-H1N1 Influenza (PCAST Report): An Engineer’s Perspective

By Luis Kun, Ph.D., FAIMBE, FIEEE

The views expressed in this op-ed are those of the author and do not reflect the official policy or position of IEEE-USA, the National Defense University, the Department of Defense, or the U.S. Government.

On 24 August 2009, the President’s Council of Advisors on Science and Technology (PCAST) released its Report to the President on U.S. Preparations for 2009- H1N1 Influenza (2009 H1N1 Report). While the report is an admirable accomplishment, and we all owe a debt of gratitude to the dedicated women and men that work tirelessly to make our lives safer and better, PCAST seems to have missed opportunities to foster greater impact by addressing this issue through the interoperability lens. Government agencies, as well as the private sector, the public health and health care infrastructure, as well as other critical infrastructures have a lot to offer in this respect.

Earlier this year, on 1-2 June, an Interoperability Summit on Health Care Transformation was convened at the National Academy of Sciences. As chair of that event, I believe that several of the issues and driving forces behind the Summit can provide important perspective on this 2009 H1N1 Report. Particularly relevant to H1N1 preparation is a discussion of factors which hinder change and impede progress — something advocates of health care transformation are all too familiar with. The Summit, co-sponsored by IEEE-USA, sought to develop a set of policy recommendations for the president and his administration on how the United States health care delivery system can and should be transformed — rather than merely reformed. The Summit's tenet says the following about resistance to change:

In the last few decades, the visions and promises born from the Information age have brought incredible changes in our lives. As with all changes, there are both, good and bad. Even when the changes, if adopted will have been good, we have many times shunned it, on account of the general comfort surrounding that which we have come to know, against that which is proposed and the unfamiliar, on account of fear. We are restrained equally from realizing the full potential that change is able to gift to us, simply because the left hand is often unaware of what the right hand is doing. In either case, the end-result is the same, where we do not receive the potential benefit, from the change that can either be adopted or implemented.

The 2009 H1N1 Report suffers from both of the aforementioned conditions.

Scientific breakthroughs and advances by mankind have often made apparent ways to improve the quality of our lives, while lowering the costs of health care in the areas of health assurance and disease prevention. Not only are we now able to learn and connect discoveries faster, but do so more efficiently and effectively. At times, our fears have restricted us from incorporating valuable and timely information against a challenge area. Consider that there are communities of interests at both, governmental and non-governmental levels, whose activities produce immensely valuable information that can be helpful to Health Care transformation; whose mission areas can contribute significantly to enhancing U.S. Health Care system quality and effectiveness. The core mission areas of these entities may not centrally be directed at driving, or assisting the U.S. Health-Care enterprise and/or practices improve. Yet, they can certainly help.

 In not being connected to the bigger picture, and in perhaps not understanding the relevance of that which on the surface appears to be insignificant information to the whole — we may have simply ignored valuable information. Consequently, we may have failed to act either individually, and/or collectively upon relevant information, and may have also failed to synergize with others that have the insight and expertise, to bridge both the knowledge and human connectivity gaps.

While the Summit stressed the importance of looking at the big picture, and looking at the problem holistically from a multidisciplinary and interdisciplinary perspective, this H1N1 Report relied chiefly on the talents of experts on virology, public health, pediatrics, medicine, epidemiology, immunology and what they called “other relevant scientific fields.”

Report Too Narrowly Focused

The Observations and Recommendations of the 2009 H1N1 Report fall into seven major categories:

1. Coordination

2. Scenarios

3. Surveillance

4. Response

5. Barriers

6. Communications

7. Future Preparedness

With the PCAST report, the problem is not to what is being said, but rather what is absent. The report seems to be too narrow and almost isolated from other relevant discussions and activities taking place in the United States, especially in the health care and public health arena, and particularly with respect to issues related to critical infrastructure. For example, the current health care reform deliberations underscore the importance and consequences of having approximately 47 million uninsured Americans. Also, both the past and present Administrations have committed to having Electronic Health Records (EHR) for every citizen by 2014. And very little is said in the PCAST report about the ways in which Health Information Technology (IT) could be used (with the exception of “Communications”) to mitigate the impact of a pandemic. The Report does not address the enormous impact of the uninsured on our Emergency Departments’ (ED) capacity, nor the assessment opportunity that EHRs / lifetime longitudinal records could provide when vaccine registry information is included. Short-term (e.g., adverse reactions) and long-term effects of vaccines on individuals, and even on populations, could be assessed.

Lack of automatic data entry is a barrier. For example, a few years ago during a food poisoning outbreak in a Colorado town, the number of incidents reported to the State, and from there to the CDC, was about five times smaller than the actual figures. In other words, when major crises occur, there is often little to no time for health care / public health practitioners in the field to enter information into computers systems. Such scenarios present very different challenges than those that exist when patients are being monitored in a hospital’s intensive care units (ICUs) and those values can be compiled by a computer automatically. In the middle of a Pandemic, when many individuals will show up in Doctors’ offices, clinics, hospitals and emergency rooms, we will have to confront this problem of who will enter the information as it is happening vs. entering it after the fact. The PCAST Report’s recommendations for upgraded new surveillance systems will not solve the issue of automatic data entry.

PCAST recommends that: "CDC engage not only traditional media, with which CDC has deep experience, but also new media and social networking channels, especially given the propensity of the 2009-H1N1 virus to infect young people."

We could approach this theme from different perspectives as well. This is the first Pandemic where many devices, including cell phones / smart-phones / PDAs, computers, television and other converging information technologies are available in the home (at least in the developed world) to allow individuals to get information as well as to provide information to others. For example, during last year’s major fires in San Diego County, California officials used reverse 9-1-1 to alert its citizens to the need to evacuate.

Many may wonder why discuss health care reform and the uninsured in the middle of an Influenza Pandemic discussion? I would like to propose a different way to look at our current situation based on additional pieces of information, which have not been taken into consideration.

What is the big picture here in the United States regarding hospital, bed, specialist capacity? In an average year, approximately 36,000 Americans die from seasonal flu, and another 200,000 need to be hospitalized and will end up requiring the use of respirators, etc. Perhaps less familiar statistic is an Associated Press (AP) story of April 2002, which estimated that every year 87 million cases of food-borne illnesses occur in the United States, including 371,000 required hospitalization, and resulting in about 5,700 deaths (AP used a CDC formula and the then “current” population). Similarly, despite the current 2009 H1N1 Pandemic, some individuals may contract regular / seasonal flu, others may have strokes, heart attacks, need dialysis, break a bone, etc. In other words many diseases, accidents and circumstances will send individuals to emergency rooms and hospitals regardless of whether we have the Pandemic or not.

The Institute of Medicine of the National Academies published a study on 14 June 2006, “The Future of Emergency Care in the United States Health System.” With the purpose of creating a vision for the future of emergency care, the committee published a series of three reports that looked at hospital-based emergency and trauma care, at pre-hospital emergency medical services (EMS), and at the special challenge of providing emergency care for children. The outcome were three volumes of the report entitled: 1) Hospital-Based Emergency Care: At the Breaking Point; 2) Emergency Medical Services: At the Crossroads; and 3) Emergency Care for Children: Growing Pains. The principal topics addressed included: overcrowding, fragmentation and lack of coordination between health care, public health and public safety; shortage of specialists; lack of disaster preparedness; and the shortcomings in pediatric emergency care. Some of the key findings drawn from all three reports could be summarized in a single sentence: The emergency care system is ill-prepared to handle a major disaster.

Many Emergency Department (EDs)s and trauma centers are overcrowded, and with many EDs at or over capacity, there is little surge capacity for a major event, whether it takes the form of a natural disaster, disease outbreak or terrorist attack.

• Overcrowding. (Drawn from Hospital-Based Emergency Care: At the Breaking Point) Critical specialists are often unavailable to provide emergency and trauma care. Three quarters of hospitals report difficulty finding specialists to take emergency and trauma calls. Key specialties are in short supply. On-call specialists often treat emergency patients without compensation due to high levels of uninsured. These specialists also face higher medical liability exposure than those who do not provide on-call coverage. Demand for emergency care has been growing fast. ED visits grew by 26 percent between 1993 and 2003, but over the same period, the number of EDs declined by 425, and the number of hospital beds declined by 198,000. ED crowding is a hospital-wide problem — patients back up in the ED because they cannot get admitted to in-patient beds. As a result, patients are often “boarded” — held in the ED until an in-patient bed becomes available — for 48 hours or more. Also, ambulances are frequently rerouted from overcrowded EDs to other hospitals that may be farther away and may not have the optimal services. In 2003, ambulances were diverted 501,000 times — an average of once every minute.

• EMS and EDs are not well equipped to handle pediatric care. (Drawn from Emergency Care for Children: Growing Pains.) Most children receive emergency care in general (not children’s) hospitals, which are less likely to have pediatric expertise, equipment, and policies in place for the care of children. Although children make up 27 percent of all ED visits, only 6 percent of EDs in the United States have all of the necessary supplies for pediatric emergencies. Many drugs and medical devices have not been adequately tested on, or dosed properly for, children. While children have increased vulnerability to disasters — for example, children have less fluid reserve, which leads to rapid dehydration — disaster planning has largely overlooked their needs.

• Emergency care is highly fragmented. (Drawn from Emergency Medical Services At the Crossroads) Cities and regions are often served by multiple 9-1-1 call centers. Emergency Medical Services (EMS) agencies do not effectively coordinate EMS services with EDs and trauma centers. As a result, the regional flow of patients is poorly managed, leaving some EDs empty and others overcrowded. EMS does not communicate effectively with public safety agencies and public health departments — they often operate on different radio frequencies and lack common procedures for emergencies. There are no nationwide standards for the training and certification of EMS personnel. Federal responsibility for oversight of the emergency and trauma care system is scattered across multiple agencies.

The PCAST Report looks at four critical pillars of a mitigation effort — vaccines, anti-viral drugs, medical care, and non-medical interventions that diminish virus spread — focusing primarily on:

1. decisions that could reduce instances of severe disease and death by accelerating the delivery and use of vaccines

2. developing integrated plans to protect especially vulnerable populations

3. ensuring access to intensive care facilities

However, other alternatives exist that should have been explored, particularly under “non-medical interventions.”

One of the recommendations under Schools and Education — calling on state and local school districts to reduce disincentives to closing schools when public health conditions warrant such closures — is good, but misses an opportunity to promote IT as a valuable tool for easing the strain on parents and students who might be home for extended periods of time during a pandemic.

Home quarantine advantage. Our homes can be the best solution for conducting quarantine — not necessarily for the sick, but to keep people healthy. Most government (local, state, federal), and private industry employees as well as academicians and high school and university students in the developed world have at their disposal a plethora of devices at home that allows them to do telework, to buy food and even medications from local stores, or even to do a telemedicine consultation. Primary Schools students may need a little bit more instruction, but perhaps schools could develop alternative way to educate them at a distance. After all, distance learning allows students to do complete reading assignments, work on special projects, etc. For those families less fortunate economically, bi-synchronous television sets accessed through a keyboard may provide an alternative for communication purposes. Having the students “work” from home may not be the best way for developing social skills, but is an alternative that we did not have decades ago, and now is possible, and could help people keep from getting infected. In addition the capacity problems may be resolved. Schools could become temporary hospitals and additional temporary beds could be set to treat those that are in need in those locations.

Health care/public health is just one of 17 critical infrastructures in the United States. All of the critical infrastructures are interdependent, so if one fails, many others could follow suit. In other instances, the effect of failure in one area upon another one will be significant. It is imperative then to treat those personnel that keep our critical infrastructures running as a top priority group, because by keeping them healthy, we keep our continuity of services running. It is also imperative to think globally and not as if this was a U.S.- centric problem. Our economy depends on other countries for supplying food, medications / vaccines, and many other goods.

Looking at capacity from supply chain management, as well as how to inform the public are other perspectives that should also be considered. For example, on 7 October2004, the Copley News Service reported:

“British inspectors closed down a pharmaceutical plant in Liverpool, England. As a result, many more Americans are likely to suffer from influenza this winter because almost half of the influenza vaccine scheduled to be sold in this country suddenly isn’t available. Such is the frailty of this nation's vaccine infrastructure, and it does not come as a surprise to most health care experts. For years, many of the vaccines that should be administered have periodically been in short supply. Recent reports by the National Vaccine Advisory Committee and the Government Accountability Office cite several reasons for these shortages: a complicated federal regulatory process, a small number of vaccine makers and the relatively low value of vaccines compared to other drugs. After a flu vaccine shortage in 2000-2001, several initiatives were advanced by the federal Centers for Disease Control to blunt the impact of future shortages. Among them were extending the vaccination period beyond mid-November; drafting contingency plans to maximize influenza vaccinations for at-risk populations; and reducing by half the dosage for healthy adults between 18 and 49 years old. These measures certainly would help this season after it was announced this week that the Chiron plant in Liverpool, which was to supply 46 million to 48 million doses of flu vaccine to the United States, was forced to cease production. Batches of vaccine were found to be contaminated with a bacterium called serratia. The other manufacturer, French drug-maker Aventis Pasteur, will supply about 54 million doses. Fortunately, Aventis is the only approved supplier of the vaccine for children 6 months to 23 months, a highly susceptible group. The other age group most at risk is those over 65 and, particularly, those over 85. Health care workers and those with chronic conditions also are in the high-risk category. Health officials say the total number of Americans in at-risk categories ranges from 90 million to 120 million, but only 50 million to 80 million people per year receive shots... But America's vaccine supply needs further support. An influenza pandemic, as occurred in 1918 killing half a million U.S. citizens, could sweep the nation again. A more recent epidemic struck the United States in 1959, causing 70,000 deaths. Any real fix must be international, and Washington must take the lead. Incentives for manufacturers, increased power for governments to take control of supplies in emergencies and a streamlined regulatory process should be among the first steps taken. This season's shortage should be a wake-up call to address the vaccine supply problem immediately.”

The public needs to know if anything has changed since the 2004 vaccine crisis. But the PCAST Report fails to answer a number of important questions:

• Where is the vaccine supply coming from? (e.g., is it all internal production or is it coming from abroad?)

• Was the PCAST charged with a specific and narrow task?

• Why is there no comprehensive analysis of the total / big picture situation?

• Perhaps to answer more in depth questions that relate to “supply chain,” capacity and other issues will require significant outside help.

• How do we assure the quality assurance of the vaccines? (Since the quantity and composition of flu vaccines produced is in most cases based upon guess-estimates, sometimes the guesses fail)

• What is the plan if the current recipe for production of 2009 H1N1 vaccines fails to meet actual need?

• Do we have a back-up plan?

Some other concerns

The public could be better served with some guidelines on which vaccines should be taken and by whom. For example, given your age and health status, should you get a seasonal flu shot or a 2009 H1N1 vaccine or both? What happens if later in the winter avian flu becomes an additional problem? Which vaccines should you then get?

These topics need to be discussed, published and disseminated through the CDC and all Web sites that normally deal with these issues globally (e.g. WHO, PAHO, etc.)

Two areas that were not dealt with in the PCAST report, but need to be addressed are: Ethical Issues and Mental Health Issues. Should we face a shortage of vaccines, who determines who gets vaccinated? And how are those determinations made? Yes, PCAST ascribes different risk groups (age-wise), depending on what type of flu vaccine we are discussing (e.g., seasonal, 2009 H1N1, Avian H5N1, etc.), but from a CIP perspective, given all the related interdependencies, we need to also consider risk from a continuity of services perspective. For example, the longshoremen at the Port of Long Beach (Calif.) are responsible for 70 percent of the imports that come from the Far East, including vaccines, medications, foods, etc. In other words, continuity of products coming from that part of the world will be at stake. How do you assure that these front line workers are protected? They need to be included as a high-risk group, as well.

According to Dr. Watson’s (NC Center for Public Health Preparedness) “Mental Health Aspects of Pandemic Flu Preparedness,”  many mental health problems can and will arise from different factors associated with a pandemic. Some of these are as consequence of isolation / quarantine, from not going to public places like restaurants, sports arenas, concerts, airplanes, etc, In other cases, mental health issues can result from negative economic impacts such as unemployment, closing of businesses, drastic decline of customers, as well as short supplies of food, medications, hospital beds, respirators, etc. In some cases, essential services such as communications, transportation and/or utilities could go down. Losses of family members, friends, co-workers or neighbors; exposure to traumatic images (e.g., on TV)  could create strong feelings of grief, as well. IT provides some avenues to be able to keep in touch through social networks with loved ones and, of course, at least viewing them through a simple TV camera installed on your cell phone and or laptop will allow people to deal with many of these issues differently from in the past when these capabilities were not available.

The cover letter of the 2009 – H1N1 Influenza PCAST Report states in the second paragraph: “The report reviews the full range of response options for minimizing negative impacts from a fall 2009-H1N1 epidemic and provides an integrated set of recommendations about how to think about hard issues and key policy decisions regarding the epidemic.” I do not believe that the full range of response options was investigated. I further believe that having in the same room individuals that possess a different set of talents could have brought additional views and potential solutions. I am convinced that many of the efforts that this Administration is seeking both in Health Care Reform as well as in Health Care IT  — that were not addressed in the PCAST Report — will help our nation address similar issues in the future. It is imperative that the issue of Critical Infrastructure Protection be treated as an integral part of the preparations for 2009-H1N1 Influenza and not as a separate subject. Many parts of the Report are uninteroperable and are perpetuated by functional disconnection.

Luis Kun has actively volunteered with IEEE-USA since 1986, where he is: founding chair of the Electronic Medical Record and High Performance Computers and Communications (HPCC) Subcommittee of the former IEEE Health Care Engineering Policy Committee; founding chair of the Bioterrorism & Homeland Security WG for the IEEE-USA Medical Technology Policy Committee (MTPC); co-founder and Member of the Genetics WG for the IEEE-USA MTPC; and founding chair of the Critical Infrastructure Protection Committee for the IEEE-USA. He is the Senior Research Professor of Homeland Security at the National Defense University.

Comments may be submitted to todaysengineer@ieee.org.