Department of Health and Human Services
 
OFFICE OF 

    
INSPECTOR GENERAL 

 
 
 
 
 
 
 
 
P H L
UBLIC    EALTH  ABORATORY 

 
T T D
ESTING  O  ETECT AND 

 
 
R B T  
EPORT  IOLOGICAL  HREATS 

 
 
 
 
Daniel R. Levinson 
  
Inspector General 

 
October 2008 
 
OEI-04-07-00750 
   
Office of Inspector General

http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as  
amended, is  to protect the integrity of the Department of  Health and Human Services  
(HHS)  programs, as well as the health and welfare of beneficiaries  served by those 
programs.  This statutory mission  is  carried  out through  a nationwide network  of  audits, 
investigations, and inspections conducted by the  following operating components:  
Office of Audit Services 
The Office  of  Audit Services  (OAS) provides auditing services  for HHS, either by  conducting  
audits  with its own audit resources or by  overseeing  audit work done by others.  Audits  
examine the performance of HHS programs and/or its grantees and contractors in carrying  
out their respective responsibilities and are intended  to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and  
mismanagement and promote economy and efficiency  throughout  HHS. 
Office of Evaluation and Inspections  
The Office  of  Evaluation and Inspections (OEI)  conducts national evaluations to  provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud,  waste, or abuse  and promoting  
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving  program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations  
of  fraud and misconduct  related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI  utilizes its resources 
by actively  coordinating with the Department  of Justice  and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to  criminal 
convictions, administrative sanctions,  and/or  civil monetary  penalties.  
Office of Counsel to the Inspector General 
The Office of Counsel to the  Inspector  General (OCIG) provides general legal services to 
OIG, rendering  advice and opinions on HHS programs  and operations and providing all 
legal support for OIGs  internal operations.  OCIG represents  OIG in all civil and 
administrative fraud and abuse cases involving HHS programs,  including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In  connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program  guidance, publishes fraud alerts, and provides other  
guidance  to  the health care industry concerning the anti-kickback statute and other  OIG  
enforcement authorities.     E X E C U T I V E   S U M M A R Y  
OBJECTIVE 
 
To assess the extent to  which State public health laboratories have 
made progress toward the Centers for Disease Control and Preventions 
(CDC) requirements intended to decrease the time needed to detect and  
report biological public health threats.  
BACKGROUND 
Since 2002, the Department of Health and Human Services has made 
available more than $7 billion in funding to increase State and local 
public health preparedness and emergency response capabilities.  These 
funds were awarded through the Office of the Assistant Secretary for 
Preparedness and Response, CDC, and the Health Resources  and  
Services Administration. 
In 2006, through its Public Health Emergency Preparedness 
Cooperative Agreement (Cooperative Agreement), CDC allocated  
approximately $766 million to 62 awardees to meet nine overarching 
preparedness goals.  Preparedness Goal 3:  Detect and Report is the 
only goal that focuses on public health laboratory testing and reporting  
of biological threats.  This goal contains two required critical tasks, with 
a total of 11 requirements.  Further, these requirements contain 
multiple elements that State public health laboratories must meet to 
decrease the time needed to detect and report biological public health 
threats.  These critical tasks and requirements have remained 
unchanged since 2005 and should be completed in 5 years, ending in 
2010. 
To meet most of the Preparedness Goal 3 testing and reporting 
requirements, State public health laboratories must coordinate with 
private clinical laboratories that perform preliminary testing and ship 
specimens to the State.  These are known as sentinel laboratories.   
Sentinel laboratories perform diagnostic tests on specimens from  
patients to identify biological agents that cause illness. When sentinel  
laboratories cannot identify the biological agents in specimens, they  
ship specimens to a confirmatory laboratory, usually the State public 
health laboratory, for further testing. 
We surveyed public health laboratory officials in all 50 States and three 
metropolitan areas (hereafter referred to as 53 States) about the extent 
to which they met 9 of the 11 testing and reporting requirements for 
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State public health laboratories specified by the Cooperative 
Agreement.    
FINDING 
All States reported meeting at least three of the CDC public health 
laboratory testing and reporting requirements that we reviewed, 
but no State met all nine.  States reported  meeting the nine public 
health laboratory testing and reporting requirements we reviewed to 
varying degrees.  At least 87 percent of States reported  meeting all 
elements in four of nine requirements:  
 	  All States reported the availability of a Biosafety Level-3  
(BSL-3) testing facility or had an agreement to use the BSL-3 
testing capacity of another jurisdiction.   
 	  Ninety-six percent of States (51 of 53) reported the capacity to test 
and report the viruses that cause smallpox, cowpox, and 
chickenpox.   
 	  Ninety-four percent of States (50 of 53) reported having the 
instrumentation and staff to perform required laboratory tests. 
 	  Eighty-seven percent of States (46 of 53) reported training public 
health laboratory personnel on all required shipping-related tasks. 
Less than 65 percent of States reported meeting all elements in  
five of nine testing and reporting requirements we reviewed, and less 
than 10 percent of States reported meeting all elements in two of these   
five requirements: 
 	  Sixty-four percent of States (34 of 53) reported  developing all 
required  elements of a laboratory operational plan. 
 	  Forty-two percent of States (22 of 53) reported testing the  
competency of their Bioterrorism Laboratory Coordinator or 
designated trainer to advise laboratory personnel on required 
shipping-related elements. 
 	  Thirty-two percent of States (17 of 53) reported  conducting exercises 
to monitor compliance with their timeliness policy for reporting test 
results.  
 	  Nine percent of States (5 of 53) reported testing the ability of 
sentinel laboratories to ship biological specimens during all three 
required timeframes:  weeknights, weekends, and holidays.   
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 	  Six percent  of States (3 of 53) reported using at least the  
CDC-endorsed definition of basic sentinel laboratory to identify 
sentinel laboratories in their jurisdictions and maintained a 
database of sentinel laboratories including all seven required 
elements.    
RECOMMENDATION 
The CDC Public Health Emergency Preparedness Cooperative 
Agreement provides funds to States to increase their public health 
preparedness and response capabilities.  To improve public health 
laboratory preparedness, States must meet specific requirements to  
decrease the time needed to detect  and report biological threats to 
public health.  These requirements  have remained unchanged since 
2005 and should be completed in 5 years, ending in 2010.   
All States reported meeting at least three of the testing and reporting 
requirements we reviewed, but no State met all nine.   
At least 87 percent of States reported meeting all elements in four of 
nine requirements that we reviewed.  Less than 65 percent of States 
reported meeting all elements in the other five requirements, and less 
than 10 percent of States reported meeting all elements in two of 
these five requirements.    
We recommend that CDC continue to assist States in meeting 
Cooperative Agreement requirements intended to decrease the time 
needed to detect and report biological public health threats.  There are 
2 years remaining before States must complete all laboratory 
preparedness requirements.  Therefore, CDC should place special 
emphasis on improving performance for the two requirements met by 
less than 10 percent of States.  CDC  could improve performance for 
these requirements by the following two methods:  
 	  determining why less than 10 percent of States conducted tests of 
their sentinel laboratories shipping capabilities outside of 
regular business hours and providing assistance to States on how 
to increase the number of tests conducted, and   
 	  ensuring that States use a consistent method to identify sentinel 
laboratories to include in their databases and that the databases 
include all required elements.   
 
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AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
CDC concurred with our overall recommendation that it should 
continue to  assist States in meeting the Cooperative Agreement 
requirements intended to decrease the time needed to detect and report 
biological public health threats.  However, CDC suggested that OIG 
revise the two methods we provided on improving performance for the 
requirements met by less than 10 percent of States.  
OIG agreed  with the recommended changes to the first method and  
revised the report accordingly, but did not incorporate the  recommended 
revisions for the second  method because we do not consider them to be  
consistent with the Cooperative Agreement.  
CDC also provided general and technical comments on our draft report.   
In its general comments, CDC noted that States have until 2010 to meet 
all the requirements we  reviewed and requested that this information 
be stated prominently in our final report.  CDC also recommended that 
OIG provide background information on how the Cooperative 
Agreement requirements were developed.    
OIG added an additional reference to the 2010 completion date in the 
Recommendation section of this final report, but did not describe how 
the requirements were  developed because that information is not 
necessary to explain our  report findings.  Finally, we have incorporated 
responses to CDCs technical comments as appropriate.  
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  T A B L E   O F   C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
  
 
 
I N T RO DUC T IO N  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1 
  
 
 
F I N D IN G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5 
  
All States reported meeting at least three of the testing and 
 
reporting requirements that we reviewed, but no State met  
             
all nine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5 
  
 
R E C O MMEN D A T ION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  15 

   Agency Comments and Office of Inspector General  

   Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  16 
  
 
 
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  18 
  
  A: 	Overview of the Centers for Disease Control and  

               Preventions Nine Public Health Emergency  

        Preparedness Goals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  18 
  
 
  B:	  Centers for Disease Control and Preventions 

               Preparedness Goal 3:  Detect and Report  . . . . . . . . . . . . . . . .  19 
 
        C:	  Sentinel Laboratory Definitions Endorsed by the Centers for 

               Disease Control and Prevention. . . . . . . . . . . . . . . . . . . . . . . .  22 
  
   
  D: 	States Grouped by the Number of Centers for Disease
  
               Control and Prevention Public Health Laboratory Testing  

               and Reporting Requirements They Reported Meeting. . . . . . . 2 4
  
 
  E:	   Agency Comments  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5
  
 
A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  29 
  
    I N T R O D U C T I O N  
OBJECTIVE 
To assess the extent to  which State public health laboratories have 
made progress toward the Centers for Disease Control and Preventions 
(CDC) requirements intended to decrease the time needed to detect and  
report biological public health threats.  
BACKGROUND 
Funding for Public Health Emergency  Preparedness and Response 
Since 2002, the Department of Health and Human Services (HHS) has 
made available more than $7 billion in funding to increase State and 
local public health preparedness and emergency response  capabilities.1   
These funds were awarded through the Office of the Assistant Secretary 
for Preparedness and Response, CDC, and the Health Resources and 
Services Administration.2  
In 2006, through its Public Health Emergency Preparedness 
Cooperative Agreement (Cooperative Agreement), CDC allocated  
approximately $766 million to 62 awardees to meet nine preparedness 
goals.3  4  See  Appendix A  for an overview of the nine preparedness 
goals. Preparedness Goal 3:  Detect  and Report is the only goal that 
focuses on public health laboratory testing and reporting of biological 
threats.  This goal contains two required critical tasks, with a total of  
11 specific requirements. Further, these requirements contain multiple 
elements that State public health laboratories must meet to  decrease  
the time needed to detect and report public health threats.  These 
critical tasks and requirements have remained unchanged since 2005 
and should be completed in 5 years, ending in 2010.  See Appendix B for 
the full text  of the public health laboratory testing critical tasks and 
requirements.  
 
1 HHS News Release, July 17, 2007.  Available online at 
http://www.hhs.gov/news/press/2007pres/07/pr20070717c.html. Accessed on 
December 18, 2007. 
2 Ibid. 
3 2006 CDC Public Health Emergency Preparedness Cooperative Agreement 
Announcement (hereafter referred to as Cooperative Agreement), pp. 4850.  Available 
online at http://www.bt.cdc.gov/planning/coopagreement/pdf/fy06announcement.pdf. 
Accessed on December 20, 2007.  
4 The 62 awardees are the 50 States, the District of Columbia, Los Angeles County,  
Chicago, New York City, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin 
jurisdictions. 
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Public Health Laboratory Preparedness  
As of December 2007, there were 247 public health laboratories in the 
United States.5  All States have at least one public health laboratory, 
and larger States have multiple public health laboratories that operate 
as a system. State public health laboratories play a crucial role in  
public health preparedness and response by testing specimens from 
patients to identify the agents that cause illness.  They then provide the 
test results to health care professionals in the community so an 
appropriate public health response can be initiated.  However, State 
public health laboratories rely on private clinical laboratories, which are 
not under the authority of State public health laboratories, to obtain 
specimens from patients.  
Clinical laboratories are often the first line of defense in public health 
response because they perform diagnostic tests ordered by physicians.  
Some clinical laboratories also perform tests to  rule out the presence of 
specific biological agents in specimens from patients.  In addition, they 
ship specimens to a confirmatory laboratory, usually the State public 
health laboratory, when further testing is required.   
Not all clinical laboratories have the capabilities to perform tests to rule  
out the presence of specific biological agents and  ship specimens to a 
confirmatory laboratory. Clinical laboratories with these capabilities 
are known as sentinel laboratories.  CDC defines sentinel laboratories 
as basic or advanced depending on their policies and procedures, as well 
as available equipment and staff training.  See Appendix C for the   
CDC-endorsed definitions of basic and advanced sentinel laboratories.6    
Related Office of Inspector General Work 
A 2002 report by the Office of Inspector General (OIG) found that State 
and local public health infrastructure was underprepared to detect and  
respond to bioterrorism.7  Insufficient laboratory capacity, supported to 
a large extent by clinical laboratories, was partially responsible for this 
lack of preparedness. 
 
5 Clinical Laboratory Improvement Amendments (CLIA)  Update, Division of  
Laboratory Services, Centers for Medicare & Medicaid Services (CMS), Laboratories by 
Type of Facility, December 2007.  Available online at 
http://www.cms.hhs.gov/CLIA/downloads/factype.pdf. Accessed on April 23, 2008. 
6 These definitions were approved by the Laboratory Response Network (LRN)  
Leadership Council. The LRN is a collaborative effort of CDC, the Federal Bureau of  
Investigation,  and the Association  of Public Health Laboratories.  
7 OEI-02-01-00550, State and Local Bioterrorism Preparedness. 
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In a 2007 report, OIG found that opportunities existed to improve State 
public health laboratory coordination with clinical laboratories to 
decrease the time  needed to detect and report a pandemic influenza 
outbreak.8   
METHODOLOGY 
Scope 
In June 2007, we surveyed public health laboratory officials in all  
50 States, the District of Columbia, New York City, and Los Angeles 
County (hereafter referred to as 53 States).9  We asked the extent to 
which they met 9 of the 11 laboratory testing and reporting 
requirements for biological threats specified by the 2006 Cooperative 
Agreement.  The survey reporting period was from June 2006 to June 
2007. 
We excluded two Cooperative Agreement public health laboratory 
testing and reporting requirements from our study.  We did not assess 
whether laboratories met the minimum requirements of the Select  
Agent Regulation or U.S. Patriot Act of 2001 (Requirement 7).  
Oversight of this requirement does not fall solely under HHS.  We also 
did not assess States compliance with the Public Health Information 
Network (PHIN) as specified by Requirement 11 because CDC officials 
stated that they had plans to substantially revise PHIN requirements 
around the time we started our study.  
We focused  our study on biological testing of specimens from  humans 
because the most recent threats to public health have been biological in 
nature (e.g., anthrax, salmonella, E. coli).  We did not ask States about 
their public health laboratory chemical or radiological testing 
capabilities. 
Data Collection 
We contacted the Cooperative Agreement Coordinators in 53 States to 
determine the most appropriate contacts to receive our public health 
laboratory preparedness survey.  We sent an electronic survey to the 
public health laboratory official identified by the Cooperative  
Agreement Coordinator in each State.   
 
8 OEI-04-07-00670, Laboratory Preparedness for Pandemic Influenza. 
9 We excluded  Chicago from our study because it does not maintain jurisdiction  over a 
public health laboratory.   
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We requested responses  to our survey about the nine biological 
laboratory testing and reporting requirements under review.  We also 
requested supporting documentation where applicable.  We  had a  
100-percent survey response rate. 
Data Analysis 
We reviewed survey responses and supporting documents to determine  
the total number of States that reported meeting each of the nine 
testing and reporting requirements under review.   
With the exception of Requirement 10, all of the  requirements under 
review contain multiple elements.  We considered that a State met a 
requirement if it reported conducting or developing all elements 
contained in the requirement.   
For example, to meet Requirement 2, States must test the competency  
of their Bioterrorism Laboratory Coordinator, or designated trainer, to  
advise laboratory personnel on five shipping-related elements:   
(1) specimen collection, (2) packaging, (3) labeling, (4) shipping, and  
(5) maintaining chain-of-custody.  We considered that a State met 
Requirement 2 if it reported meeting all five shipping-related elements.   
Similarly, to meet Requirement 5, States must develop  operational 
plans that include 11 elements.  We considered that a State met 
Requirement 5 if it reported that its operational plans contained all  
11 elements.    
Further, we  noted cases  in which States reported conducting or 
developing some, but not all, of the required elements. 
Limitations 
We relied on  self-reported  survey responses and supporting 
documentation to determine whether States met each testing and  
reporting requirement. We did not confirm the States ability to meet 
the requirements.    
Finally, we did not evaluate whether the Cooperative Agreement 
requirements and all elements decrease the time to detect and report 
public health threats as intended. 
Standards  
This study was conducted in accordance with the Quality Standards for 
Inspections issued by the Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency.  
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All States reported meeting at least three of the CDC  Under the Cooperative Agreement,  
public health laboratory testing and reporting   State public health laboratories 
must meet specific requirements 
requirements that we reviewed, but no State     
intended to decrease the time 
met all nine 
needed to detect and report 
biological public health threats.  States reported  meeting the  public 
health laboratory biological testing and reporting requirements that we 
reviewed to varying degrees.  See Appendix D for the number of States 
grouped by the number of requirements that they reported  meeting.   
In addition, States reported meeting the nine testing and reporting 
requirements that we reviewed to differing extents.  For example, all 
States reported meeting Requirement 6, and three States reported  
meeting Requirement 1.    
Table 1 shows the number of States that reported meeting each public 
health laboratory biological testing and reporting requirement reviewed.  
 
  Table 1:  States Reporting That They Met Each Public Health  
Laboratory Biological Testing and Reporting Requirement 
  Requirement*  Number of States  Percentage of  
That Reported   States That 
Meeting the  Reported Meeting 
 
Requirement  the Requirement  
  Requirement 6:  Ensuring availability of  53  100% 
a Biosafety Level-3 (BSL-3) facility  **  
  Requirement 9:  Ensuring the testing  51   96% 
  and reporting of selected viruses  
Requirement 8:  Ensuring necessary   50   94% 
  instrumentation and staff  
Requirement 4:  Ensuring laboratory   46  87% 
 
personnel training  
  Requirement 5:  Developing laboratory   34  64% 
operational plans  
 
Requirement 2:  Testing the Bioterrorism  22  42% 
  Laboratory Coordinator 
Requirement 10: Monitoring a  17   32% 
  timeliness policy  for reporting results 
Requirement 3:  Testing sentinel   5  9% 
 
laboratory shipping capability 
  Requirement 1:  Maintaining a sentinel  3  6% 
laboratory database 
                                                  
* We excluded Requirements 7 and 11 from our review. 
** BSL is a four-tiered system (BSL-1, BSL-2, BSL-3, BSL-4) that provides increasing 
 levels of safety for laboratory  workers and containment of biological agents. 
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At least 87 percent of States reported meeting all elements in four of nine 
testing and reporting requirements that we reviewed 
All States reported the availability of a Biosafety Level-3 facility or had an 
agreement to use the testing capacity of another jurisdiction.   Public health 
laboratories must ensure the availability of a BSL-3 facility to maintain 
the safety of laboratory personnel conducting tests on dangerous biological 
agents. BSL-3 facilities are also designed to prevent the escape of 
dangerous biological agents into the environment. 
All States reported having BSL-3 testing capacity, as specified by  
Requirement 6.  Ninety-four percent of States (50 of 53) reported that 
they have an operational BSL-3 facility.  The three States without a 
facility reported satisfying the requirement for BSL-3 capacity through 
formal arrangements with other jurisdictions.  
Ninety-six percent of States reported the capacity to test and report 
specimens suspected of containing the viruses that cause smallpox, 
cowpox, and chickenpox.  The virus that causes smallpox (Variola major) 
is considered a critical biological agent because of its threat to public 
health if used in a terrorist event.10  Although they are not considered  
to be critical biological agents, the viruses that cause cowpox (Vaccinia ) 
and chickenpox (Varicella) may lead to a skin rash that resembles a 
rash caused by the smallpox virus.  Therefore, laboratories must be able 
to test for the viruses that cause cowpox and chickenpox to rule out the  
possibility that a pox-like skin rash was caused by the smallpox virus.   
Ninety-six percent of States (51 of 53) reported having the capability to 
test and report specimens suspected of containing Variola major, 
Vaccinia, and Varicella, as specified by Requirement 9. 
Ninety-six percent of States (51 of 53) reported having the capability to 
conduct tests to rule out the presence of Variola major and report 
specimens suspected of that virus.11   Of this group, 40 of 51 States 
reported in-State testing capability to rule out Variola major and the 
remainder reported satisfying this requirement through formal 
arrangements with other jurisdictions.     
All 53 States reported having in-State capacity to test and report 
Vaccinia and Varicella in specimens.   
 
10 CDC. Critical Biological Agents:  Disease Reporting as a Tool for Determining 
Bioterrorism Preparedness, p.  1.  Available online at 
http://www2.cdc.gov/phlp/docs/cdc.horton.web.pdf. Accessed on December 20, 2007.  
11 Due to safety concerns, CDC allows only a limited number of laboratories to perform  
testing that specifically identifies Variola major.  
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Ninety-four percent of States reported having the appropriate instrumentation 
and appropriately trained staff to perform selected CDC laboratory tests.  
Public health laboratories must have appropriate instrumentation and 
trained staff to perform specific laboratory tests to identify biological 
agents that threaten public health.12    
Ninety-four percent of States (50 of 53) reported having the 
instrumentation and staff to perform the laboratory tests specified by 
Requirement 8. 
Eighty-seven percent of States reported that public health laboratory 
personnel are trained on all five required shipping-related elements. 
It is often necessary to ship specimens to a laboratory with more 
advanced testing expertise to positively identify biological agents that 
threaten public health. Laboratory specimens  must be properly handled  
at all stages of the shipping process to ensure personnel safety and to 
maintain specimen integrity.  
Eighty-seven percent of States (46 of 53) reported training public health 
laboratory personnel on all five required shipping-related elements as 
specified by Requirement 4: (1) packaging, (2) labeling, (3) shipping,  
(4) coordinating routing,  and (5) maintaining chain-of-custody.13  Almost 
all States conducted training, but not on all five  elements as required by 
the Cooperative Agreement.  
Less than 65 percent of States reported meeting all elements in  
five of nine testing and reporting requirements that we reviewed, and less 
than 10 percent of States reported meeting all elements in two of these 
five requirements 
Sixty-four percent of States reported developing laboratory operational 
plans that contained all 11 required elements. By developing operational 
plans for laboratory practices, laboratory officials can define  procedures 
and assign responsibility in advance of a public health event. In 
addition, written plans help to ensure consistency and continuity in 
laboratory practices.    
 
12 The Cooperative Agreement requires at least one public health laboratory in each  
jurisdiction to have the appropriate instrumentation and trained staff to perform  
Polymerase Chain Reaction and  Time-Resolved  Fluorescence.  
13 All States that participated in the pilot phase of this study informed us that they  
consider coordinating routing to be a part of  maintaining chain-of-custody.  Therefore, our 
survey asked  about maintaining chain-of-custody only.  If a State responded that it 
conducted training on  maintaining chain-of-custody, we also gave the State credit for 
conducting training on coordinating routing. 
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Sixty-four percent of States (34 of 53) reported that their public health 
laboratories  have developed operational plans that contain all  
11 elements specified by Requirement 5. 
Table 2 shows that at least 81 percent of States (43 of 53) reported 
developing at least one element of the operational plan, but not all  
11 elements as required  by the Cooperative Agreement.   
 
Table 2:  States Reporting That They Had Developed Required 
Elements of an Operational Plan  
 
Required Element*  Number of States  Percentage of States 
That Reported   That Reported  
  Developing   Developing Element 
Element 
Worker safety   53  100% 
  Sample transport and handling  52  98% 
Appropriate working conditions  52  98% 
Threat assessment   52  98% 
  Secure storage of critical agents  52  98% 
Quality control and assurance  51  96% 
Adherence to laboratory practices  51  96% 
 
Staffing and training of personnel  50  94% 
Intake and testing prioritization  48  91% 
Proficiency testing   47  89% 
 
Appropriate levels of supplies and  43  81% 
equipment 
  * See Requirement 5 in Appendix B for the text of the required elements. 
 
Forty-two percent of States reported testing the competency of their 
Bioterrorism Laboratory Coordinator, or designated trainer, to advise 
laboratory personnel on all five required shipping-related elements.  
Laboratory personnel must properly  handle laboratory specimens at all 
stages of the shipping process to ensure personnel safety and to 
maintain specimen integrity.  A central point of contact for  
shipping-related advice ensures that laboratory personnel receive 
accurate and consistent  information.  
Forty-two percent of States (22 of 53) reported testing the competency of 
their Bioterrorism Laboratory Coordinator (Coordinator), or a 
designated trainer, to advise laboratory personnel on all five  
shipping-related elements as specified by Requirement 2:  (1) specimen 
collection, (2) packaging, (3) labeling, (4) shipping, and (5) maintaining 
chain-of-custody.    
Fifty percent of States (11 of 22) that reported testing the competency of 
their Coordinator, or designated trainer, on all five elements noted that a  
person other than the Coordinator (e.g., Safety Officer, Packaging and 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   8   F I N D I N G   
Shipping Coordinator) advised laboratory personnel on shipping 
procedures.  
Table 3 shows that at least 49 percent of States (26 of 53) reported 
testing the competency of their Coordinator or designated trainer to  
advise on at least one element, but not on all five elements as required  
by the Cooperative Agreement.   
                                                   
  Table 3:  States Reporting That Their Public Health Laboratories  
Tested Their Coordinators Competency  To Advise on Required 
  Shipping-Related Elements 
Element  Number of States  Percentage of States 
    Reporting Tests   Reporting Tests  
Packaging  30  57% 
  Shipping  30  57% 
Labeling  29  55% 
  Specimen collection  26  49% 
Chain-of-custody   26  49% 
 
 
Thirty-two percent of States reported conducting exercises to monitor 
compliance with their timeliness policy for reporting test results.  
To ensure timely responses to public health events, States establish 
timeframes  for reporting confirmatory results to sentinel laboratories 
seeking assistance in identifying biological agents.  By monitoring 
timeliness policy compliance, State personnel may identify weaknesses 
in their policies in advance of a real event.  
Thirty-two percent of States (17 of 53) reported  conducting exercises to  
monitor compliance with their timeliness policy on sending confirmatory 
results to sentinel laboratories (Requirement 10).14   Three States 
reported that they did not conduct exercises, but considered monitoring 
their response times to real events (e.g., suspected plague and anthrax 
incidents) to be tests of their timeliness policies.15    
Although 32 percent of States conducted exercises, 68 percent of States  
(36 of 53) reported having a written timeliness policy for reporting 
confirmatory results to  sentinel laboratories.  These States  reported  
that their public health laboratory timeliness policies established 
 
14 The Cooperative Agreement requires States to monitor compliance with their 
timeliness policy, but it does not specify  how.   During the pilot phase of this study, States 
informed  us that they monitored compliance through exercises.  Therefore, we used  
exercises as an indicator of compliance. 
15 Our survey did not ask States whether they used real events to monitor compliance 
with their timeliness policy.   
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   9   F I N D I N G   
specific timeframes for confirming the presence  of bioterrorism and/or  
nonbioterrorism agents in specimens.  For example, one State 
established an 8-hour timeframe for preliminary identification of both 
anthrax and West Nile Virus.  Another State established the timeframe 
for preliminary identification of anthrax as 4 to 6 hours.   
Nine percent of States reported testing the ability of sentinel laboratories to 
ship biological specimens to a confirmatory laboratory on weeknights, 
weekends, and holidays.  Because a public health event can occur at any 
time, sentinel laboratories must be prepared to ship biological 
specimens to an appropriate confirmatory laboratory 24 hours a day,  
7 days a week. 
Nine percent of States (5 of 53) reported testing sentinel laboratories 
ability to ship specimens during all three timeframes specified by 
Requirement 3weekends, weeknights, and holidays.  Fifty-three  
percent of States (28 of 53) reported not conducting tests in any of the 
three specified timeframes. 
Table 4 shows that a minimum of 23 percent of States (12 of 53) 
reported conducting tests in at least one required  timeframe, but not in 
all three timeframes as required by the Cooperative Agreement.  
                               
 
Table 4:  States Reporting That Their Public Health Laboratories  
Tested the Ability of Sentinel Laboratories To Ship Specimens 
 
During Three Required Timeframes  
Required Timeframe  Number of States  Percentage of States 
  Reporting Tests   Reporting Tests   
Weekends  19  36% 
  Weeknights  15  28% 
Holidays  12  23% 
 
 
In contrast to tests conducted on  weeknights, weekends, and holidays, 
72 percent of States (38 of 53) reported testing sentinel laboratories 
ability to ship specimens to a confirmatory laboratory, usually the State 
public health laboratory, on weekdays during regular business hours.    
States reported that sentinel laboratories are tested on weekdays 
during regular business hours by three predominant methods: (1) State 
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packaging and shipping drills, (2) the College of American Pathologists 
Laboratory Preparedness  Survey, and (3) routine shipments.16    
Table 4 on the previous page shows the number of States that reported  
testing sentinel laboratories ability to ship specimens during the three 
required timeframes.  However, the table does not give an indication of 
the percentage of all sentinel laboratories in the  United States that 
participated in testing. 
Based on their respective criteria, States estimated that there were 
4,079 to 4,199 sentinel laboratories in their jurisdictions.  The total 
number of sentinel laboratories in the United States depends on the  
criteria used by each State to designate a laboratory as a sentinel 
laboratory.  States use different criteria when designating a sentinel 
laboratory.  Some States use the CDC-endorsed  definition of basic and  
advanced sentinel laboratory, while other States base this designation 
on the laboratorys testing and shipping capabilities. 
For example, one State reported that it considers the least technically 
capable laboratory to be a sentinel laboratory as long as it can recognize 
when to send specimens to the State.  Another State reported that it 
does not have a written definition for sentinel laboratory, but considers  
all hospital and Indian Health Services laboratories that perform  
microbiology testing to be sentinel laboratories. 
Table 5 shows that States reported testing between 8 and 14 percent of 
sentinel laboratories (337 to 559 laboratories) ability to ship specimens 
during the three required timeframes.17    
                                    
  Table 5:  Sentinel Laboratories Performing Shipping  Tests  
During the Required Timeframes  
  Required Timeframe  Number of   Percentage of Sentinel 
  Sentinel  Laboratories Tested out  
Laboratories  of All Sentinel 
 
Tested   Laboratories, (n=4,079) 
                                        Weekends  559  14% 
Holidays  497  12% 
 
Weeknights  337  8% 
 
 
16 In the College of American Pathologists Laboratory Preparedness Survey, laboratories 
receive specimens and  are evaluated on how  well they follow established procedures, 
including packaging and shipping.   
17 To be conservative, we used the low range of the total estimate of sentinel laboratories 
when calculating percentages. 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   11   F I N D I N G
   
In contrast to the percentage of sentinel laboratories tested on 
weeknights, weekends, and holidays, States reported testing the ability 
of 29 percent of sentinel laboratories (1,175 laboratories) to ship 
specimens on weekdays during regular business hours.   
Six percent of States used at least the CDC-endorsed definition of basic  
sentinel laboratory to identify sentinel laboratories in their jurisdictions and 
maintained a database of sentinel laboratories including all seven required 
elements.   Public health laboratories rely on sentinel laboratories to obtain 
specimens from patients.  Therefore, it is critical that States accurately 
identify sentinel laboratories in their jurisdictions and maintain a 
database of their contact information and testing  capabilities.   
To meet Requirement 1,  States must use the CDC-endorsed  definition of  
sentinel laboratory to identify sentinel laboratories in their  jurisdictions  
and develop a sentinel laboratory database including seven required 
elements.    
The CDC-endorsed definition of sentinel laboratory includes definitions for 
a basic and an advanced sentinel laboratory.  The Cooperative Agreement 
does not specify whether States should use the basic or advanced  
definition when determining which laboratories to include in their 
databases.  To be conservative, we considered a State to have used the 
CDC-endorsed definition of sentinel laboratory if its definition contained 
at least the four elements of a basic sentinel laboratory.18    
Although all but one State maintained a sentinel laboratory database,  
only 6 percent of States (3 of 53) reported using  at least the four 
elements of the CDC-endorsed  definition of basic sentinel laboratory 
when determining which laboratories to include in their database and 
maintaining a database containing all seven required database 
elements. 
Sixty-four percent of States (34 of 53) reported that they use at least the 
four elements of the CDC-endorsed  definition of basic sentinel laboratory  
when designating a laboratory as a sentinel laboratory.  In most cases, 
State definitions of sentinel laboratory also included some elements of an  
advanced sentinel laboratory. 
 
18 The Cooperative Agreement does not contain the CDC-endorsed definition of sentinel 
laboratory.  We obtained the definition directly from CDC officials.  
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Table 6 shows that at least 74 percent of States (39 of 53) used at least one 
element of the CDC-endorsed definition of a basic sentinel laboratory, but 
not all four  elements, in their State  definition.      
                                                  
  Table 6:  States Reporting That They Incorporate At Least the 
Required Elements of the CDC-endorsed Definition of Basic 
  Sentinel Laboratory in Their State Definition 
Required Element  Number   Percentage of  
of States That  States That 
 
Incorporated   Incorporated  
Element  Element 
 
The laboratory has policies and  50  94% 
procedures for referring suspicious 
  samples to the nearest Laboratory  
Response Network (LRN) laboratory in 
  its jurisdiction.* 
The laboratory is certified under the  46  87% 
Clinical Laboratory Improvement 
 
Amendment of 1988 (CLIA) by CMS. 
The laboratory is inspected by a CMS  45  85% 
 
agent, a CMS-approved accreditation 
organization, or the State (for CLIA-
  exempt laboratories). 
The laboratory has policies and  39  74% 
  procedures for referring samples to an 
advanced sentinel laboratory. 
  * The LRN is a system of public health  and clinical laboratories through which
 
unidentified specimens are progressively tested until a positive identification is 
 
  obtained.  Laboratories in the LRN are categorized into three levels according to
  
their expertise:  sentinel, reference, and  national.
   
 
States must maintain a sentinel laboratory database that includes 
seven required elements.  Although all States but one maintained a 
sentinel laboratory database, 9 percent of States (5 of 53) maintained a 
database with all 7 required elements.   
Table 7, on the following page, shows  that at least 17 percent of States 
(9 of 53) reported developing at least one element of the database, but 
not all seven elements  as required  by the Cooperative Agreement. See   
Requirement 1 in Appendix B for the full text of the required  elements. 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   13   F I N D I N G
   
 
 
Table 7:  States in Which Public Health Laboratories Maintain the 
Required Elements of a Sentinel  Laboratory Database  
 
Element  Number  Percentage  of  
of States  States That 
  That  Maintained 
Maintained  Element 
  Element 
Name  52  98% 
Contact information   50  94% 
 
Certification status  33  62% 
BioSafety level  29  55% 
 
Partnership in State or CDC Health Alert  28  53% 
Network  
  Rule out capability of selected  17  32% 
bioterrorism agents 
      C  o n  ta  c t   in  f o r m  a tion for out-of-State  9  17% 
confirmatory laboratories used by the 
jurisdictions sentinel laboratories 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   14     R E C O M M E N D A T I O N  
 
The CDC Public Health Emergency Preparedness Cooperative 
Agreement provides funds to States to increase their public health 
preparedness and response capabilities.  To improve public health 
laboratory preparedness, States must meet specific requirements to  
decrease the time needed to detect  and report biological threats to 
public health.  These requirements  have remained unchanged since 
2005 and should be completed in 5 years, ending in 2010.   
All States reported meeting at least three of the testing and reporting 
requirements we reviewed, but no State met all nine.   
At least 87 percent of States reported meeting all elements in four of 
nine requirements that we reviewed.  Less than 65 percent of States 
reported meeting all elements in the other five requirements, and less 
than 10 percent of States reported meeting all elements in two of 
these five requirements.    
We Recommend That CDC Continue To Assist States in Meeting 
Cooperative Agreement Requirements Intended To Decrease the Time 
Needed To Detect and Report Biological Public Health Threats 
There are 2 years remaining before States must complete  all 
laboratory preparedness requirements.  Therefore, CDC should place 
special emphasis on improving performance for the two requirements 
met by less than 10 percent of States.  CDC could improve 
performance for these requirements by the following two methods: 
 	  Determining why less than 10 percent of States conducted tests of 
their sentinel laboratories shipping  capabilities outside of regular 
business hours, and providing assistance to States on how to 
increase the number of tests conducted.  Because a public health 
event can occur at any time, sentinel laboratories must be prepared 
to ship biological specimens to an appropriate confirmatory 
laboratory 24 hours a day, 7 days a week.  We recognize that  
sentinel laboratories are not under  the authority of State public 
health laboratories and that States must rely on voluntary sentinel 
laboratory participation in shipping tests.  However, during a real 
event, States can conduct confirmatory testing and report results 
only as quickly as they receive properly shipped specimens from 
sentinel laboratories.   
 	  Ensuring that States use a consistent method to identify sentinel 
laboratories to include in their databases and that the databases 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   15   R E C O M M E N D A T I O N   
include all required elements.  CDC should determine whether 
the method  of identifying sentinel laboratories should be based on 
the current CDC-endorsed definitions of sentinel laboratory or by 
another method, such as the laboratorys testing and shipping  
capabilities.  If the identification is based on the CDC-endorsed  
definitions, CDC should clarify whether State databases should 
include basic and/or advanced sentinel laboratories.  By assisting 
States to consistently identify sentinel laboratories, CDC can help 
ensure that States are working with  the appropriate population 
of sentinel laboratories intended by the Cooperative Agreement.  
By ensuring that sentinel laboratory databases include all 
required elements, States will have  the information necessary to 
coordinate with laboratories that will play a key role in a public 
health response before an event occurs. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
CDC concurred with our overall recommendation that it should 
continue to  assist States in meeting the Cooperative Agreement 
requirements intended to decrease the time needed to detect and report 
biological public health threats.   
However, CDC did not concur with the first method we provided on 
improving performance for the requirements met by less than  
10 percent of States.  OIG agreed with CDCs recommended changes to 
our first method and revised the report accordingly. 
Regarding the second method, CDC concurred that it should determine 
how sentinel laboratories are identified.  However, CDC noted that 
States should have some flexibility in determining the functional 
criteria for a laboratory to be considered a sentinel laboratory.  CDC 
also proposed that we revise our language to reflect that CDC should 
work with States to assess the effectiveness of different definitions of a 
sentinel laboratory and provide States with guidance on the basic 
criteria for a laboratory to be included in a database of sentinel 
laboratories.  OIG did not incorporate these recommended changes 
because we  do not consider them to  be consistent with the Cooperative  
Agreement requirement for States to use the CDC-endorsed  definition 
of a sentinel laboratory when developing their databases.  
CDC also provided general and technical comments on our draft report.   
In its general comments, CDC noted that States have until 2010 to meet 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   16   R E C O M M E N D A T I O N   
all the requirements we  reviewed and requested  that this information  
be stated prominently in our final report.  CDC also recommended that 
OIG provide background information on how the Cooperative 
Agreement requirements were developed.    
We noted in our draft report that States have until 2010 to complete the 
Cooperative Agreement requirements we reviewed.  This information 
was included in the Background section of the Executive Summary and  
Introduction.  We have also added this information in the 
Recommendation sections of this final report.   We did not add additional 
background information on how the Cooperative Agreement 
requirements were developed because that information is not necessary 
to explain our report findings.   
Finally, we have incorporated responses to CDCs technical comments  
as appropriate.  The full text of CDCs comments is provided in 
Appendix E. 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   17     A P P E N D I X ~ A
 
Overview of the 

Centers for Disease Control and Preventions 

Nine Public Health Emergency Preparedness Goals 

 
 
1. 	 Preparedness Goal 1, Prevent: This goal contains six critical tasks intended to 
increase the use and development of interventions known to prevent human illness 
from chemical, biological, and radiological agents and from naturally occurring health 
threats. 
2. 	 Preparedness Goal 2, Prevent: This goal contains seven critical tasks intended to 
decrease the time needed to classify health events as terrorism or naturally occurring, 
in partnership with other agencies. 
3. 	 Preparedness Goal 3, Detect/Report:  This goal contains two critical tasks intended to 
decrease the time  needed to  detect and report chemical, biological, and radiological 
agents that cause threats to the publics health in tissue, food, or environmental 
samples. 
4. 	 Preparedness Goal 4, Detect/Report:  This goal contains six critical tasks intended to 
improve the timeliness and accuracy of information regarding threats to  the publics 
health as reported by clinicians and through electronic early event detection, in  real 
time, to those who need to know. 
5. 	 Preparedness Goal 5, Investigate: This goal contains four critical tasks intended to 
decrease the time needed to identify causes, risk factors, and appropriate interventions 
for those affected by threats to the publics health. 
6. 	 Preparedness Goal 6, Control: This goal contains 33 critical tasks intended to 
decrease the time needed to provide countermeasures and health guidance to those 
affected by threats to the publics health. 
7. 	 Preparedness Goal 7, Recover: This goal contains two critical tasks intended to 
decrease the time needed to restore health services and environmental safety to  
preevent levels. 
8. 	 Preparedness Goal 8, Recover: This goal contains three critical tasks intended to 
  increase the long-term followup provided to those affected by threats to  the publics 
health. 
9. 	 Preparedness Goal 9, Improve:   This goal contains four critical tasks intended to 
decrease the time needed to implement recommendations from after-action reports 
following threats to the publics health. 
   
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Centers for Disease Control and Preventions 

 Preparedness Goal 3:  Detect and Report 

 
Decrease the time needed to detect and report chemical, biological, and radiological agents 
that cause threats to the publics health in tissue, food, or environmental samples. 
Target Capability:  Public Health Laboratory Testing 
Required Critical Task 1:  
Increase and maintain relevant laboratory support for identification of biological, chemical, 
radiological, and nuclear agents in clinical (human and animal), environmental, and food 
specimens. 
Requirement 1: Develop and maintain a database of all sentinel (biological)/Level Three 
(chemical) laboratories in the jurisdiction using the Centers for Disease Control and  
Prevention (CDC)-endorsed definition, which includes: 
 	  Name 
 	  Contact information 
 	  Biosafety Level (BSL) 
 	  Whether the laboratory is a health alert network partner 
 	  Certification status 
 	  Capability to rule  out Categories A and B bioterrorism agents per State-developed 
proficiency testing or College of American Pathologists bioterrorism module proficiency 
testing 
 	  Names and contact information for in-State and out-of-State reference laboratories  
used by each of the jurisdictions sentinel/Level Three laboratories 
 
Requirement 2:  Test the competency of a chemical terrorism laboratory coordinator and  
bioterrorism laboratory coordinator to advise on  proper collection, packaging, labeling, 
shipping, and chain-of-custody of blood, urine, and other clinical specimens. 
Requirement 3: Test the ability of sentinel/Level Three labs to send specimens to a 
confirmatory Laboratory Response Network (LRN) laboratory on nights, weekends, and 
holidays. 
Requirement 4: Package, label, ship, coordinate routing, and maintain chain-of-custody of 
clinical, environmental, and food specimens/samples to laboratories that can test for agents 
used in biological and chemical terrorism. 
 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   19   A P P E N D I X ~ B  
Requirement 5:  Continue to develop or enhance operational plans and protocols that include: 
 	  Specimen/samples transportation and handling 
 	  Worker safety 
 	  Appropriate BSL working conditions for each threat agent 
 	  Staffing and training of personnel 
 	  Quality control and assurance 
 	  Adherence to laboratory methods and protocols 
 	  Proficiency testing to include routine practicing of LRN-validated assays as well as 
participation in the LRNs proficiency testing program electronically through the LRN 
Web site 
 	  Threat assessment in collaboration with local law enforcement and the Federal 
Bureau of Investigation to include screening for radiological, explosive, and chemical  
risk of samples 
 	  Intake and testing prioritization 
 	  Secure storage of critical agents 
 	  Appropriate levels of supplies and equipment needed to respond to bioterrorism  
events, with a strong emphasis on surge capacities needed to effectively respond to a 
bioterrorism incident 
Requirement 6: Ensure the availability of at least one operational BSL-3 facility in your 
jurisdiction for testing for biological agents.  If one is not immediately available, BSL-3 
practices, as outlined in  the CDC-National Institutes of Health publication Biosafety in 
Microbiological and Biomedical Laboratories, 4th Edition, should be used (see 
www.cdc.gov/od/ohs) or formal arrangements (i.e., Memorandum of Understanding) should be 
established with a neighboring jurisdiction to provide this capacity. 
Requirement 7: Ensure that laboratory registration, operations, safety, and security are 
consistent with both the minimum requirements  set forth in Select Agent Regulation   
(42 CFR 73) and the U.S. Patriot Act of 2001 (P.L. No. 107-56) and subsequent updates. 
Requirement 8: Ensure that at least one public health laboratory in your jurisdiction has the 
appropriate instrumentation and appropriately trained staff to perform CDC-developed and 
validated real-time rapid assays for nucleic acid amplification (Polymerase Chain Reaction) 
and antigen detection (Time-Resolved Fluorescence). 
Requirement 9:  Ensure  the capacity for LRN-validated testing and reporting of Variola 
major, Vaccinia, and Varicella viruses in human  and environmental samples either in the 
public health laboratory or through agreements with other LRN laboratories. 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   20   A P P E N D I X ~ B  
Required Critical Task 2:  
Increase the exchange of laboratory testing orders and results.  
Requirement 10: Monitor compliance with public health agency (or public health agency lab) 
policy on timeliness of reporting results from a confirmatory LRN lab back to the sending 
sentinel/Level Three lab (i.e., feedback and linking of results to relevant public health data) 
with a copy to CDC as appropriate. 
Requirement 11: Comply with Public Health Information Network Preparedness Connecting 
Laboratory Systems and Outbreak Management Functional Areas to enable the linkage of 
laboratory orders and results from sentinel/Level Three and confirmatory LRN labs to 
relevant public health data, and maintenance of chain-of-custody. 
 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   21     A P P E N D I X ~ C
 
 
 Sentinel Laboratory  Definitions Endorsed by the Centers for Disease Control and 

Prevention 

 
Basic Sentinel Clinical Laboratory: 
 
1. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) by the Centers for Medicare & Medicaid Services (CMS) for the applicable 
subspecialty within the specialty of microbiology. 
2. The laboratory is inspected successfully by CMS, a CMS agent, a CMS-approved 
accreditation organization, or, for a CLIA-exempt laboratory, by that laboratorys State. 
3. The laboratory has policies and procedures for referral of diagnostic specimens to an 
Advanced Sentinel Laboratory. 
4. The laboratory has policies and procedures for direct referral of suspicious specimens or  
isolates to the nearest Laboratory Response Network (LRN) reference laboratory in its 
jurisdiction. 
 
Advanced Sentinel Clinical Laboratory: 
 
1. The laboratory is certified under CLIA by CMS for the applicable subspecialty within the 
specialty of microbiology and meets the requirements to perform high-complexity testing. 
2. The laboratory is inspected successfully by CMS, a CMS agent, a CMS-approved 
accreditation organization, or, for a CLIA-exempt laboratory, by that laboratorys State. 
3. The laboratory has policies and procedures for direct referral of suspicious specimens or  
isolates to the nearest LRN reference laboratory in its jurisdiction. 
In addition to the above criteria, Advanced Sentinel Laboratories shall meet the following: 
4. Have a Class II or higher Certified Biological Safety Cabinet. 
5. Comply with Biosafety Level 2 (BSL-2) practices.19   
6. Have policies and procedures in place for use  of additional respiratory  protection, including 
a definition of when such use is necessary, as well as documentation of safe use  
(e.g., N-95 fit-testing). 
7. Have policies and procedures, including the LRN Sentinel Level Clinical Microbiology 
Laboratory Guidelines, that are available and can be downloaded from the American Society  
for Microbiology Web site:  http://www.asm.org/Policy/index.asp?bid=6342. 
 
19 Department of Health and Human Services.  Biosafety in Microbiological and 
Biomedical Laboratories, 4th Edition. 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   22   A P P E N D I X ~ C  
8. All personnel have been trained,  with demonstrated competency, and are fully aware of the 
details contained within each LRN Sentinel Level Clinical Microbiology Laboratory Guideline. 
9. Personnel have been trained and certified in guidelines on packing and shipping of 
infectious substances.20  
10. Have procedures to track and account for decontamination of laboratory biological waste 
(specimens,  cultures).  At a minimum, ensure that any contract or procedure for  
waste/disposal is available for inspection in the laboratory safety or waste disposal manual. 
It is further  highly recommended that Advanced Sentinel Laboratories comply with the 
following: 
11. The microbiology laboratory operates under negative pressure as recommended by the 
American Institute of Architecture (AIA) Guidelines for Construction of Healthcare  
Facilities.21  If a microbiology laboratory is planning to remodel or construct a new facility, it 
should be designed to operate under negative air pressure as recommended by the AIA. This 
applies only to new construction or remodeling. 
12. There is onsite, terminal decontamination capability, e.g., autoclaving, for disposal of 
wastes categorized as BSL-3 or Select Agent. 
 
 
20 Federal Register, Part IV, Department of Transportation, 49 CFR pt. 172, Hazardous 
Materials: Security Requirements for Offerors and Transporters of Hazardous Materials; 
Final Rule. 
21 American Institute of Architecture.  Guidelines for Construction of Healthcare  
Facilities, 2001 Edition. 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   23     A P P E N D I X ~ D
 
States Grouped by the Number of Centers for Disease Control and 

Prevention Public Health Laboratory Testing and Reporting Requirements 

They Reported Meeting 

 
 
   
 
18 
 
15 
 
  es 
at 11 
St
 of 
r 
e
 b
m
u 6 
N
 
 
2
1 
 
 
1 2 3 4 5 6 7 8 9 
  Number of Requirements States Reported Meeting  
 
 
  OEI-04-07-00750   PUBLIC HEALTH  LABORATORY  TESTING  TO DETECT AND REPORT BIOLOGICAL  THREATS   24    A P P E N D I X ~ E  
 
Agency Comments
  OEI-04-07-00750  PUBLIC HEALTH LABORATORY TESTING TO DETECT AND REPORT BIOLOGICAL THREATS  25  A P P E N D I X   ~   E  
  OEI-04-07-00750  PUBLIC HEALTH LABORATORY TESTING TO DETECT AND REPORT BIOLOGICAL THREATS  26  A P P E N D I X   ~   E  
  OEI-04-07-00750  PUBLIC HEALTH LABORATORY TESTING TO DETECT AND REPORT BIOLOGICAL THREATS  27  A P P E N D I X   ~   E  
  OEI-04-07-00750  PUBLIC HEALTH LABORATORY TESTING TO DETECT AND REPORT BIOLOGICAL THREATS  28  AAA  PPP APPP CEEE KNNN NDDD IIIO XXXW    L~~~ E    AAAD    G M E N T S
 
This report was prepared under the  direction of  Robert A. Vito, Acting 
Regional Inspector General for Evaluation and Inspections in the 
Atlanta regional office, and Dwayne F. Grant, Deputy Regional 
Inspector General. 
Mary-Elizabeth Harmon served as the lead analyst for this study.  
Other principal Office of Evaluation and Inspections staff from the  
Atlanta regional office who contributed to this report include Peggy W. 
Daniel; central office staff who contributed include Mark Richardson; 
Jodi Nudelman from the New York regional office also contributed.  
 
 
 
 
 
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