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Prepared Witness Testimony The House Committee on Energy and Commerce
SARS: Assessment, Outlook, and Lessons Learned
Subcommittee on Oversight and Investigations
Dr. Jared N. Schwartz M.D., Ph.D.
Chairman Greenwood, Congressman Deutsch, distinguished Committee members. I am Dr. Jared Schwartz, a practicing pathologist and microbiologist from Charlotte, North Carolina, Chair of the College of American Pathologists (CAP) National Laboratory Preparedness Committee and Secretary Treasurer of the College. I was also recently appointed by Health and Human Services Secretary Tommy Thompson to the Clinical Laboratory Improvement Advisory Committee. On behalf of the CAP, I appreciate the opportunity to participate in today's hearing before the Energy and Commerce Subcommittee on Oversight and Investigations to assess the emerging threat of Severe Acute Respiratory Syndrome (SARS) and what we can do to improve our ability to contain its spread and safeguard the public. The CAP is a national medical specialty society representing over 16,000 pathologists who provide pathology services in community hospitals, independent clinical laboratories, academic medical centers and federal and state health care facilities across the country. CAP members have extensive expertise in providing and directing laboratory services and serve as inspectors in the College Laboratory Accreditation Program. In addition, the CAP provides laboratories with a wide array of proficiency testing programs and educational solutions to assist in the improvement of the laboratory's performance. These programs combined are designed to improve the quality of laboratory services and to ensure the accuracy and reliability of test results. Role of the Clinical Laboratory in Identifying SARS As a Physician Director of a large integrated laboratory, I understand first-hand the challenges we face in both accurately identifying and responding to the public health threat of emerging pathogens, such as SARS. It is important to recognize that your local laboratory and community hospital are the first line of defense against this new disease. The laboratory and its hospital facility are responsible for the initial evaluation, preliminary diagnosis and ongoing care and treatment of patients who become infected with SARS. My testimony will focus on the critical role of the clinical laboratories and community hospitals as the first contact with individuals who can be infected with SARS or other communicable pathogens. We must prepare ourselves now for an oncoming surge of new patients. Most individuals with possible SARS have, in fact, other causes for their symptoms and present a diagnostic challenge for both clinicians and laboratory professionals. This highlights the essential role of the clinical laboratory - that laboratory in a hospital or established as an independent adjunct to the hospital lab providing diagnostic services to residents of a local community. The CAP represents pathologists who are Physician Directors of our nation's clinical laboratories, perform forensic and anatomic pathology, with the common objective of providing a diagnosis as to the cause of disease through laboratory medicine. The clinical laboratory has a major responsibility for ruling out SARS cases so they can be appropriately treated and for referring those cases where SARS cannot be ruled out to the public health system for definitive diagnosis and management. As such, pathologists are on the front lines in diagnosing viral and other causes of microbiological disease. This outbreak of SARS demonstrates the critical role of the clinical laboratory, as partners with government and public health laboratories, to contain any new emerging pathogen, particularly at the community level. Diagnosing a patient with SARS may be significantly delayed without the vigilance of a pathologist, clinical scientist and other laboratory professionals. The laboratory has the responsibility to rule out flu-like cases that are not SARS so individuals receive proper treatment and are not inappropriately quarantined. By the same token, the laboratory will also have the responsibility to determine and refer those flu-like cases where SARS may in fact be present as new tests become available. This analysis is critical because it allows for actions and resources to be quickly and effectively targeted to those individuals where SARS is diagnosed or cannot be ruled out. The laboratory staff and the pathologist medical decision-makers are essential to the proper treatment and thus helping to control the spread of the disease. If not accurately identified, patients with SARS could be sent home to infect others instead of being treated and if necessary quarantined. Pathologists also conduct autopsies both as forensic medical examiners and at community hospitals to determine the cause of death. In this role, pathologists serve as an early warning system in detecting new diseases and provide critical information to our public health system about the course and etiology of the disease in the population. Assessing SARS as a Public Health Threat Prior to assessing the impact of a SARS epidemic in the Untied States, it is important to understand why this illness has emerged as such an important global public health threat. In many ways, SARS is no different from any other flu-like illness to which Americans are frequently exposed. SARS shares many of the components of common respiratory illness - it appears to be caused by a virus, it is spread by respiratory droplets and its symptoms can mimic other respiratory infection. Why then have governments, the media and public health officials around the world moved with unprecedented speed to alert the public to the possible threat of SARS? The answer is multi-factorial. SARS appears to be a new virus and no vaccine is available, at this time, to prevent this disease. This leaves the population vulnerable to attack. SARS can spread rapidly and kill. The frequent international travel of the population; crowded living conditions; the ability to be exposed without personal contact (from respiratory droplets or from surface contact); among others all contribute to a formula for worldwide outbreaks. U.S. health officials are investigating 54 probable cases of SARS in this country with another 237 cases under close surveillance. Worldwide, 6,234 cases have been reported in 27 countries associated with 435 deaths. The economic impact of SARS in affected countries has been devastating despite the relative small number of cases as compared to cases of influenza worldwide. Although it is encouraging to know that SARS cases are declining in some areas, we cannot become complacent. SARS is likely to follow seasonal patterns much like many other respiratory viruses. SARS could become dormant through some seasons only to return in others. That's why this apparent current lull should not be viewed as victory or that our work has been done. To the contrary, we should use this time to marshal our resources and collaborate with other countries to combat this threat and enhance our local communities' response capabilities. This is an opportunity that should not be squandered. SARS is one of many new infections that have surfaced in the recent years -- West Nile, Hantavirus, Ebola, Nipah, Hendra, AIDS among others. Subsequent to 9/11, we also experienced an unprecedented bioterrorist attack with anthrax. In fact, one of the anthrax attacks occurred here in our nation's capital. There is no reason to believe that these outbreaks - either through natural occurring agents or the intentional distribution of microbiological agents will not continue. Furthermore, it is important to note that whether the infectious and dangerous agent is the result of mother nature or a terrorist, our health system both public and private must be prepared to respond. And, in many ways, the response needs are the same. We applaud the Centers for Disease Control and Prevention in recognizing the importance of a responsive and complete public health infrastructure to meet these threats. Much as been done to improve the CDC's communication and coordination with clinical laboratories regarding bioterrorism. Similarly, the CDC's communications to the medical community on SARS has been excellent. However, more needs to be done particularly in regional planning and ensuring a seamless link between the nations clinical laboratories, hospitals and public health resources if our nation is to contain this outbreak as well as other microbial threats. Current State of Diagnostic Testing Diagnostic tests for SARS are currently under development. The tests can give both false positive and false negative results. A recent Canadian study found that just 40% of likely SARS patients actually tested positive for the virus. At this point, the technology to perform SARS tests is available only at sophisticated public health laboratories. There is a need for readily available diagnostic tests which clinical laboratories can use at the local level. Unfortunately, a test of this nature could be years away. The uncertainty in SARS testing reinforces the important contribution of the clinical laboratories in being able to perform those tests that can clearly identify those individuals with symptoms of SARS who have the common flu or bacterial pneumonia - thereby screening out individuals who are not infected with SARS. This will become extremely important when large numbers of patients with symptoms of fever and cough present for diagnosis during the onset of the next flu season. Protecting the Clinical Laboratory Workforce No preparedness and containment strategy can succeed without adequate healthcare workforce protection. We have all heard the news stories about health care workers who have contracted SARS in the course of caring for patients infected with the disease. An emphasis must be placed on finding the most effective ways to protect health care workers. Failure to do so will not only spread the disease to other hospital patients and the population at large, but will also put at risk the very individuals we will need to rely on if an outbreak occurs. In the U.S., patients first present to the local emergency department or to a private health care practitioner for care. Patient specimens are then sent to the laboratory to determine the presence of disease, and in this case, the possibility of SARS. However, when the specimen arrives at the laboratory for analysis, the presence of SARS is not known. This reinforces the need for laboratory professionals and other front line health care workers to follow universal precautions in handling and collecting specimens. Laboratory procedures such as centrifuging and opening sample containers may release microbial agents to the air that can spread the disease to workers and patients in the area. The clinical laboratory and local medical provider community will look to the CDC and other government health agencies to provide them with the latest and most scientifically valid knowledge about respirator effectiveness and use, handling precautions and modes of transmission. With hospitals and providers operating on shoestring budgets, this becomes an even more critical issue. Health care infrastructure weaknesses should not be a barrier to our preparedness efforts. As was learned from our fighting troops in Iraq, success in decreasing casualties in a war is dependent on having the very best resources, equipment and training. Nothing less should be available to our nation's hospital and laboratory workers in their battle against bioagents. Lessons Learned -- Need for a Strong Public-Private Health Sector Partnership The SARS experience can teach us many lessons. From my perspective as a pathologist in my local community working with clinicians and public health officials, one of the most important lessons is the need to enhance the vital link between the private and public health sector, particularly at the local level. While it is clearly important to prepare, coordinate and respond globally, we must implement locally to successfully control the outbreak of SARS and other diseases. Proper policies and procedures for coordination and communication between the private sector laboratories and the public health system have improved since 9/11 but need to be strengthened so that potential SARS cases, and other emerging threats, can be quickly identified and managed. However, I would caution against reinventing our system for each new disease that comes along. This would be a costly and unworkable approach. Actions taken at the federal, state and local level in collaboration with our private health care system has done much to improve our response capabilities with respect to bioterrorism. We should continue to improve and refine these existing mechanisms for dual use in terms of both biological agents used in a bioterrorist act as well as microbial agents that are naturally occurring. As a private sector initiative, the CAP has developed programs to educate and train pathologists and laboratory personnel to improve response capabilities. The College has developed a Laboratory Preparedness educational tool designed for laboratories to better identify microbiological agents that could be used in a bioterrorist attack. This program sends surrogate microbial samples to laboratories. These safe samples mimic biological agents and are sent to the laboratory in a blind manner so we can assess the laboratory's ability to accurately identify select agents of bioterrorism. The program also educates laboratories about how to properly coordinate with the public health infrastructure for referral and reporting activities. There are plans underway to expand this program to ensure that clinical labs are prepared to identify emerging pathogens, including SARS. As we think about lessons learned from this outbreak, its comforting to know that progress has been made in terms of public health system procedures for responding to biological threats of any nature, but the system remains fragmented. Every county and state can have different procedures and methods for reporting infectious disease and handling outbreaks. This does not allow for seamless reporting from the clinical laboratories and local health providers and does not allow for integrated electronic surveillance systems. The technology is available to implement interoperability coordination and electronic reporting and its adoption should be accelerated. A March report from the prestigious Institute of Medicine indicates that today's outlook with regard to microbial threats to health is bleak. Microbial threats will present us with new surprises every year. We applaud the continued modernization of the public health system. However, there is a critical need for more coordination at the highest level in order to ensure full implementation at the local level. Our public health system would benefit from an interconnected electronic communication network to monitor for disease outbreaks. The world is interconnected on a daily basis -- our nations clinical and public health resources should be just as interconnected. The CAP was pleased to assist CDC in providing timely communication to laboratory personnel following the anthrax outbreaks and working to improve the private sector clinical lab connection to the public health networks. We are committed to continued collaboration with the Department of Health and Human Services and other government agencies to respond to public health emergencies and bioterrorism events. We have witnessed the severe economic consequences and panic that has resulted in other countries from SARS outbreaks. We need to be sure our local communities have a coordinated plan to handle their outbreak in the near future. The CAP believes that private sector resources, such as those we offer, can contribute much to the coordination and improvement of our collective efforts in our battle against microbes from all sources. Conclusion In closing I would like to reemphasize the key points of my testimony: 1. SARS is one of many new infections that have surfaced in the recent years. Since 9/11 we have also experienced an unprecedented bioterrorist attack. There is no reason to believe that this trend - either through natural occurring agents or intentional distribution of microbiological agents will not continue. Regardless, the need for preparedness is the same, both nationally and locally. 2. The outbreak of SARS demonstrates the critical role of the clinical laboratory, as partners with government and public health laboratories, to contain any new emerging infectious disease. As the point of initial evaluation for individuals who can be infected with SARS, clinical laboratories are one of the first lines of defense against this new disease. Significant responsibility rests with the clinical laboratories for the preliminary diagnosis of the patient, including the ability to accurately rule out non-SARS cases and appropriate referral of those displaying characteristics of SARS. 3. Education on workforce safety is extremely important. Laboratory professionals and other front line health care workers must be fully informed about the need to follow universal precautions in handling and collecting specimens. Our health care workers deserve the very best equipment and technology to protect them as they combat this disease. 4. It is expected that SARS will follow a seasonal pattern, becoming dormant through some seasons and returning in others. This possible lull provides an opportunity to marshal our resources and work with other countries to combat this threat. This is an opportunity that should not be squandered. 5. As we think about lessons learned from this outbreak, its comforting to know that progress has been made in terms of public health system procedures for responding to biological threats of any nature, but the system remains fragmented. The world is interconnected on a daily basis -- our nations clinical laboratories, hospitals and public health resources should be just as interconnected. 6. There is much to learn about the etiology and diagnostic testing for SARS. Questions remain about the cause of the disease and how best to identify it in patients. Proper policies and procedures for coordination and communication between the private sector laboratories and the public health system have improved since 9/11 but need to be strengthened so that potential SARS cases, and other emerging threats, can be quickly identified. 7. The diagnosis of SARS may be significantly delayed if not for a vigilant pathologist, clinical scientist and other laboratory professionals. Pathologists, through conducting autopsies for the cause of death, serve as an early warning system to detect new diseases and provide critical information about the course and etiology of the disease in the population. 8. As a private sector initiative, the CAP has developed programs to educate and train pathologists and laboratory personnel to improve response capabilities. The CAP has developed a Laboratory Preparedness educational tool designed to educate laboratories to better identify microbiological agents that could be used in a bioterrorist attack with plans underway to expand the questions to SARS. We look forward to working with the public and private sector in similar efforts.
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