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me bioterrorism and public health officials noted that, while expansion
laboratory capacity is vital to preparedness, efforts to identify more
otic agents may be beyond the scope of all but the largest health
partments and therefore should be a regional or state-based activity.
onsequently, some experts have suggested research into determining the
ility of developing a network of regional laboratories capable of rapid
agnostic testing.25 Determining current capacity will be a key first step in
sessing the need for a regional network. Currently, the number of public
alth and other laboratories that can handle those viruses considered
ost harmful (those classified as requiring Biosafety Level-3 or Biosafety
vel-4 equipment, trained staff, and safety procedures in place) is
known.26 CDC information indicates that most states lack the public
alth laboratory capacity to handle many of those viruses that CDC has
assified as dangerous and identified as high priority because of risk to
tional security and public health. Specifically, in fiscal year 1999, less
an half of the over 40 states and localities receiving funding for
oratory capacity through CDC's bioterrorism preparedness grant
ogram reported having advanced capacity for rapid testing for at least
ur critical biologic agents.27 Within the veterinary community, a USDA
Ficial told us that probably fewer than 20 veterinary laboratories across
e country have the capacity to test for Biosafety Level-3 pathogens, and
veterinary laboratories have Biosafety Level-4 capacity.28

Ensuring Ade
Expertise

hemical and Biological Terrorism, p. 73.

iosafety Level-3 pathogens are considered serious or lethal with the potential for aerosol
nsmission. Biosafety Level-4 pathogens are dangerous, exotic agents posing high risk of
-threatening disease that also are transmitted through the air and with an unknown risk
ransmission; Biosafety Level-4 pathogens have no vaccines or drugs available for
atment. Officials told us that three federal laboratories have Biosafety Level-4 capacity
I that an inventory of Biosafety Level-3 laboratories is currently under way.

ritical biologic agents are those considered by CDC to be of potential concern for
terrorism and which must be registered with CDC when acquired or transported. CDC
classified laboratories based on their biosafety and containment capacities and other
tors, level A, for example, representing those with low-level biosafety facilities and level
epresenting those with the highest-level containment and expertise in the diagnosis of
e and dangerous biological agents. CDC reported that in fiscal year 1999, 19 of 43 funded
tes or localities self-reported a level C laboratory capability for at least four of the critical
logic agents. According to CDC, level C capability requires a Biosafety Level-3 facility.

pecifically, this official indicated that there are 9 Biosafety Level-3 veterinary laboratories t can study Biosafety Level-3 pathogen-infected animals, and fewer than 10 additional erinary laboratories that have Biosafety Level-3 facilities for doing diagnostics or other animal work.

quate Staffing and

Several officials commented on the declining capacity and expe the federal and state public health laboratory infrastructure, par it relates to zoonotic and vector-borne diseases. At the time of th the Fort Collins laboratory capacity was considered to be low, a needed specialist positions had been eliminated or left vacant a experienced staff had left. Similarly, CDC reported that only a fe and even fewer local health departments have trained personne resources to adequately address vector-borne diseases. Accordi and other officials, the infrastructure of laboratories with the ca handle such diseases has deteriorated in recent decades. The nu laboratories and extent of capacity have dropped, and the staffin plant, and financial support of many remaining laboratories hav affected.

New York State, prior to the outbreak, lacked the capacity to ad vector-borne diseases. A New York State laboratory official indi at one time the state had 5 or 6 staff to perform mosquito survei track viruses. In recent years the laboratory's staff had been cut funding was diverted to other public health priorities. By contra Connecticut officials indicated that they had-after a similar en with eastern equine encephalitis, another mosquito-borne virusmosquito surveillance in 1997, at a cost of about $200,000.29 Bec ongoing surveillance program, the state was able to quickly resp outbreak, placing mosquito-monitoring devices in potentially in areas and identifying the appropriate places to spray. According program official, having baseline data-for example, data on wh mosquitoes of concern resided in previous years-allowed the s make informed decisions about where to spray.

29 Officials told us that since the West Nile outbreak last fall, funding for these state has increased.

285899

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sting for West Nile taxed those parts of the laboratory system that were aling with the outbreak-and in some ways, affected what some of these boratories were normally expected to do. The New York laboratory that as testing samples for St. Louis encephalitis was also dealing with an itbreak of Escherichia coli O157:H7 at the same time.30 Both the New ork State and CDC Division of Vector-Borne Infectious Disease boratories were quickly inundated with requests for tests, and because of e limited capacity at the New York laboratories, the CDC laboratory ndled the bulk of the testing. CDC officials reported that nearly all the ›rt Collins Arbovirus Disease Branch laboratory staff at one point was orking on the response to the virus. Normally, the CDC laboratory nctions as a reference laboratory for arboviruses, maintaining the chnology and capability to accurately diagnose viruses of this type.31 In is case, it was acting largely as a diagnostic laboratory, testing patient mples to determine who had the virus and who did not. Officials dicated that the CDC laboratory would have been unable to respond to other outbreak, had one occurred at the same time. Some officials also escribed what were considered to be unfortunate aspects of CDC's taking the role of the diagnostic laboratory. Typically, the CDC laboratory's role ould be to confirm test results rather than to perform diagnostic testing. this case, in assisting the state in performing the diagnostic testing, CDC cused on determining whether individual patients had St. Louis acephalitis (and then West Nile) rather than identifying other possible uses of illness. This was considered by some to be unfortunate from the andpoint of the individual patients, whose diagnoses could therefore be elayed. Testing at the state laboratory from 95 patients with suspect viral fections found 16, or about 17 percent, of the patients positive for viruses her than West Nile.

C. coli are normal bacterial inhabitants of the intestines of most animals, including mans, where they suppress the growth of harmful bacteria and synthesize vitamins. owever, a minority of strains cause illness in humans. E. coli O157:H7, first identified as a man pathogen in 1982, is a strain that causes severe abdominal cramping and diarrhea at can become heavily bloody. Although people usually get well without treatment, the ness can be fatal.

CDC's Division of Vector-Borne Infectious Diseases, Arbovirus Disease Branch, functions a World Health Organization Collaborating Center for Reference and Research on boviruses.

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Improving the laboratory network is key to improving the labo capacity to respond to surges in workload and to provide the n technologies, staff, and expertise to respond to outbreaks. Net linkages among federal, state, academic, and possibly private s laboratories may also be needed, in part to clarify responsibilit involved laboratories for providing surge capacity, diagnostic t other critical roles in emergency situations. CDC's internal inve concluded that the agency should enlist help from academic la The California researcher who conducted some of the diagnost laboratory work on the West Nile outbreak was brought in by o New York State's Department of Health because they learned o innovative research his laboratory was developing to quickly a accurately identify the viral causes of unexplained deaths from encephalitis.32 Some involved officials indicated that the Califo laboratory's involvement was fortuitous in allowing a laborator consumed with diagnostic testing for the outbreak to focus on the types of tests required to eventually identify the virus. On th hand, some officials also indicated that this laboratory's unplan involvement contributed to confusion about which laboratories performing tests and the types of tests being performed.

Those involved in responding to the West Nile outbreak have c that with a more formal network and clearer roles,

necessary tests to accurately identify the virus could have be sooner, and

• the resulting confusion about which federal and other labora involved in the process and the tests each laboratory was pe could have been avoided or minimized.

32CDC officials from Atlanta were also involved in the discussion regarding in researcher. Because tests can take a considerable amount of time, a key state involved in the decision indicated that test results were not expected for wee Consequently, officials did not inform the Fort Collins laboratory scientists tha been given to the California laboratory.

owever, while many agree that more should be done to develop the
boratory network, the plans for such a network are still being developed.
OC's planned laboratory response network for bioterrorism-linking
blic health laboratories at the local, state, and federal levels-is still
der development. Private, veterinary, and USDA laboratories are not
-t part of the network.

33

ssessment of the public health infrastructure by public health experts,
d CDC's strategic plan for preventing emerging infectious diseases, also
int out the need for defining and building the laboratory network. The
stitute of Medicine workshop that assessed the capabilities of the public
d private sectors for identifying emerging infections reported that surge
pacity in response to an outbreak is an area in which the public health
boratory should define its core capability and standards, including the
ique and complementary roles of the public and private sector
poratories.34 CDC's strategic plan has a goal to strengthen the public
alth infrastructure in part by strengthening CDC's capacity to serve as
e national and international reference laboratory for the diagnosis of
fectious diseases.35

Challenges
Between N.
Unnatural l
Common E
Preparedne

he laboratory response network, which would link clinical laboratories to public health encies, is discussed in a report containing recommendations of a CDC workgroup. See iters for Disease Control and Prevention, “Biological and Chemical Terrorism: Strategic n for Preparedness and Response: Recommendations of the CDC Strategic Planning rkgroup," Morbidity and Mortality Weekly, Vol. 49, No. RR-4 (April 21, 2000).

he workshop also concluded that specialized laboratory techniques in modern biology
I the skilled personnel needed to perform those tests are usually too costly for most
oratories but could be obtained through the use of a regional system and private-public
tnership. See Public Health Systems and Emerging Infections, p. 21.

e plan similarly addresses goals and strategies related to other lessons learned
cussed in this report, including improving disease surveillance and outbreak response;
lied research to develop diagnostic tests, drugs, vaccines, and surveillance tools; public
Ith infrastructure and training; and disease prevention and control. See Centers for
ease Control and Prevention, Preventing Emerging Infectious Diseases: A Strategy for
21st Century (Atlanta, Ga.: U.S. Department of Health and Human Services, 1998).

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