Department of Health and Human Services
 

OFFICE OF 

INSPECTOR GENERAL 

PUBLIC HEALTH LABORATORY 


TESTING TO DETECT AND 


REPORT BIOLOGICAL THREATS
 

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 OIG’s 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. 
 

Δ EXECUTIVE SUMMARY 

OBJECTIVE 

To assess the extent to which State public health laboratories have 

made progress toward the Centers for Disease Control and Prevention’s 

(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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EXECUTIVE SUMMARY 

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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EXECUTIVE SUMMARY 

•	 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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EXECUTIVE SUMMARY 
 

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 CDC’s technical comments as appropriate. 

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Δ TABLE OF CONTENTS 

EXECUTIVE SUMMARY ..................................... i 
 

INTRODUCTION ........................................... 1 
 

FINDING ................................................... 5 
 

All States reported meeting at least three of the testing and

reporting requirements that we reviewed, but no State met 

all nine................................................ 5 
 

RECOMMENDATION ...................................... 15

 Agency Comments and Office of Inspector General 

Response............................................. 16 
 

APPENDIXES ............................................. 18 
 

A: Overview of the Centers for Disease Control and 

 Prevention’s Nine Public Health Emergency 

Preparedness Goals.................................. 18 
 

B: Centers for Disease Control and Prevention’s 

 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....... 24 
 

E: Agency Comments .................................. 25 
 

ACKNOWLEDGMENTS .................................... 29 
 
 

 

 

Δ INTRODUCTION 

OBJECTIVE 

To assess the extent to which State public health laboratories have 

made progress toward the Centers for Disease Control and Prevention’s 

(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. 48–50. 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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INTRODUCTION 

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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INTRODUCTION 

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. 

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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. 

3 
 

 

 

INTRODUCTION 

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 President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

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Δ FINDINGS 

 

 

Δ 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 

Under the Cooperative Agreement, 

State public health laboratories 

must meet specific requirements 

intended to decrease the time 

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 Th

Laboratory Biological Testin

at They Met Each Public Health 

g and Reporting Requirement 

Requirement* Number of States 

That Reported 

Meeting the 

Requirement 

Percentage of 

States That 

Reported Meeting 

the Requirement 

Requirement 6: Ensuring availability of 

a Biosafety Level-3 (BSL-3) facility ** 

53 100% 

Requirement 9: Ensuring the testing 

and reporting of selected viruses 

51 96% 

Requirement 8: Ensuring necessary 

instrumentation and staff 

50 94% 

Requirement 4: Ensuring laboratory 

personnel training 

46 87% 

Requirement 5: Developing laboratory 

operational plans 

34 64% 

Requirement 2: Testing the Bioterrorism 

Laboratory Coordinator 

22 42% 

Requirement 10: Monitoring a 

timeliness policy for reporting results 

17 32% 

Requirement 3: Testing sentinel 

laboratory shipping capability

 5 9% 

Requirement 1: Maintaining a sentinel 

laboratory database 

3 6% 

* 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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FINDING 

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. 

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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. 

6 
 

 

FINDING 

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. 

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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. 

7 
 

 

FINDING 

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 T

Elements of 

hat They Had Dev

an Operational Plan 

eloped Required 

Required Element* Number of States 

That Reported 

Developing 

Element 

Percentage of States 

That Reported 

Developing 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 

equipment 

43 81% 

* 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 

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FINDING 

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 Coordinator’s Competency To Advise on Required 

Shipping-Related Elements 

Element Number of States 

Reporting Tests 

Percentage of States 

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 

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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. 

9 
 

 

 

FINDING 

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 3—weekends, 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 

Reporting Tests 

Percentage of States 

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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FINDING 

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 laboratory’s 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 

Sentinel 

Laboratories 

Tested 

Percentage of Sentinel 

Laboratories Tested out 

of All Sentinel 

Laboratories, (n=4,079) 

Weekends 559 14% 

Holidays 497 12% 

Weeknights 337 8% 

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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. 

11 
 

 

 

FINDING 
 

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. 

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18 The Cooperative Agreement does not contain the CDC-endorsed definition of sentinel 

laboratory. We obtained the definition directly from CDC officials. 

12 
 

 

 

 

FINDING 

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 

of States That 

Incorporated 

Element 

Percentage of 

States That 

Incorporated 

Element 

The laboratory has policies and 

procedures for referring suspicious 

samples to the nearest Laboratory 

Response Network (LRN) laboratory in 

its jurisdiction.* 

50 94% 

The laboratory is certified under the 

Clinical Laboratory Improvement 

Amendment of 1988 (CLIA) by CMS. 

46 87% 

The laboratory is inspected by a CMS 

agent, a CMS-approved accreditation 

organization, or the State (for CLIAexempt laboratories). 

45 85% 

The laboratory has policies and 

procedures for referring samples to an 

advanced sentinel laboratory. 

39 74% 

* 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. 

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FINDING 
 

Table 7: States in Which Public Health Laboratories Maintain the 

Required Elements of a Sentinel Laboratory Database 

Element Number 

of States 

That 

Maintained 

Element 

Percentage of 

States That 

Maintained 

Element 

Name 52 98% 

Contact information 50 94% 

Certification status 33 62% 

BioSafety level 29 55% 

Partnership in State or CDC Health Alert 

Network 

28 53% 

Rule out capability of selected 

bioterrorism agents 

17 32% 

Contact information for out-of-State 

confirmatory laboratories used by the 

jurisdiction’s sentinel laboratories 

9 17% 

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Δ 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. 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 

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RECOMMENDATION 

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 laboratory’s 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 CDC’s 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 

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RECOMMENDATION 

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 CDC’s technical comments 

as appropriate. The full text of CDC’s comments is provided in 

Appendix E. 

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Δ APPENDIX~A 

Overview of the 

Centers for Disease Control and Prevention’s 

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 public’s 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 public’s 

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 public’s 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 public’s 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 public’s 

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 public’s health. 

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Δ APPENDIX~B 

Centers for Disease Control and Prevention’s 

 Preparedness Goal 3: Detect and Report 

Decrease the time needed to detect and report chemical, biological, and radiological agents 

that cause threats to the public’s 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 jurisdiction’s 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. 

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APPENDIX~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 LRN’s 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. 

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APPENDIX~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. 

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Δ APPENDIX~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 laboratory’s 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 laboratory’s 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. 

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19 Department of Health and Human Services. “Biosafety in Microbiological and 

Biomedical Laboratories,” 4th Edition. 

22 
APPENDIX~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. 

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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. 

23 
 

Δ APPENDIX~D 

States Grouped by the Number of Centers for Disease Control and 

Prevention Public Health Laboratory Testing and Reporting Requirements 

They Reported Meeting 

Number of States 

1 

6 

15 

18 

11 

2

1 2 3 4 5 6 7 8 9 

Number of Requirements States Reported Meeting 

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Δ APPENDIX~E 

Agency Comments
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APPENDIX ~ E 
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APPENDIX ~ E 
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APPENDIX ~ E 
APPENDIX ~ A Δ ACKNOWLEDGMENTS 

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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