DEPARTMENT OF HEALTH &. HUMAN SERVICES Office of Inspector General
 

(l"'''C£~'~ '..'.. 

~."'''la Washington, D.C. 20201
 

OCT 2 4 2007
 

TO:	 Dr. Julie L. Gerberding, M.D., M.P.H.
 

Director
 

Centers for Disease Control and Prevention
 

FROM:	 Daniel R. Levinson~ t. ~
 

Inspector General
 

SUBJECT: Memorandum Report-Laboratory Preparedness for Pandemic Influenza,
 

OEI-04-07-00670
 

This memorandum report provides information on laboratory pandemic influenza preparedness 

as requested in April 2007 by offcials at the Centers for Disease Control and Prevention (CDC). 

The Office of Inspector General (GIG) sureyed State public health laboratory offcials in June 

2007 about the extent to which they conducted the eight critical tasks for public health laboratory 

testing as required by the Pandemic Influenza Guidance Supplement to the 2006 Public Health 

Emergency Preparedness Cooperative Agreement, Phase II (the Guidance).l 

All States reported that their public health laboratories performed the first two critical tasks, to 

conduct year-round influenza testing and to detect and subtype influenza viruses.2 Although not 

specifically required by the Guidance, all States reported public health laboratory capability to 

subtype H5 influenza.3 The H5 subtyping test is curently only available to public health 

laboratories. Consistent with this, most States reported that they have no sentinel laboratory 

capability to subtype H5 influenza.4 However, this capability may be necessary to meet 

increased testing needs during an H5 influenza pandemic. 

All States reported that their public health laboratories did not perform at least one of the six 

remaining critical tasks. For the tasks involving both public health and clinical laboratories, 

i The eight critical tasks are outlined in Attachment B u~der Pandemic Influenza Preparedness Goal 3: Detect and Report Target 

Capabilty 38. The Guidance is available online at httD://www.bt.cdc.gOv/Dlanning/coODagreement/Ddf/Dhase2-Danfluguidance.Ddf. Accessed August 27,2007.
 

2 There are different types of influenza viruses (e.g., HI, H3, H5). Subtyping refers to the ability to distinguish one type of
 

influenza from another.
 

3 The H5 strain of influenza normally infects birds, but it has the potential to cause a human pandemic.
 

4 Sentinel laboratories conduct initial screenings of biological specimens and refer suspicious specimens to public health
 

laboratories. 
 

 

 

 

 

Page 2 – Dr. Julie L. Gerberding, M.D., M.P.H. 

States reported performing the required activities for public health laboratories to a greater extent 

than for clinical laboratories.5 

BACKGROUND 

Funding for Pandemic Influenza Preparedness and Response 

In 2005, Congress appropriated $350 million for upgrading State and local capacity to prepare 

for and respond to an influenza pandemic. These funds have been awarded by the Department of 

Health and Human Services (HHS) in phases.6 In March 2006, CDC awarded $100 million 

(Phase I) to 62 jurisdictions to identify gaps in their preparedness based on 60 critical tasks. 7 8 

An updated version of these critical tasks is included in Attachment B of the Guidance. As of 

July 2006, CDC had awarded an additional $225 million to the same jurisdictions to address 

these preparedness gaps (Phase II). CDC plans to award the remaining $25 million through 

competitive grants to eligible recipients. Awardees are expected to complete tasks supported by 

the Guidance in 3 years, ending in 2009. By 2009, CDC expects that awardees should be fully 

prepared to respond to and control an influenza pandemic. 9 

In August 2007, the Secretary of HHS announced another $75 million for pandemic influenza 

preparedness.10 These grants will supplement funds dedicated to strengthen the ability of the 

Nation’s health care community to respond to bioterrorism, infectious diseases, and natural 

disasters. 

Public Health Laboratory Testing Requirements for Pandemic Influenza Preparedness 

The eight required critical tasks for public health laboratory testing as specified by the Phase II 

Guidance are to: 

1.	 maintain the ability to test for influenza viruses year-round; 

2.	 perform polymerase chain reaction (PCR) testing for rapid detection and subtyping of 

influenza viruses; 

3.	 electronically exchange specimen-level data among clinical laboratories, the State public 

health laboratory, and CDC; 

5 The tasks involving both clinical and public health laboratories are critical tasks 3, 5, 6, and 7.
 6 Emergency Supplemental Appropriations Act To Address Hurricanes in the Gulf of Mexico and Pandemic Influenza Act, 2006, 

Pub. L. No. 109-148, Division B, Title II, Chapter 6 (Dec. 30, 2005).
 7 These funds supplement the 2006 Public Health Emergency Preparedness Cooperative Agreement. Available online at 

http://www.bt.cdc.gov/planning/coopagreement/pdf/fy06announcement.pdf. Accessed August 27, 2007. 8 The 62 jurisdictions are the 50 States, the District of Columbia, the cities of Chicago and New York, Los Angeles County,
 

Puerto Rico, the U.S. Virgin Islands, and the 6 Pacific Basin jurisdictions.
 9 The Guidance, page 4, available online at http://www.bt.cdc.gov/planning/coopagreement/pdf/phase2-panflu-guidance.pdf. 

Accessed August 27, 2007. 

10 News Release available online at https://www.hhs.gov/news/press/2007pres/08/pr20070830a.html. Accessed September 3, 

2007.
 
 

 

Page 3 – Dr. Julie L. Gerberding, M.D., M.P.H. 

4.	 institute surveillance for influenza-like illness among laboratory personnel working with 

novel influenza viruses; 

5.	 develop and exercise an operational plan to augment the capacity of public health and 

clinical laboratories to meet the needs of the jurisdiction during an influenza pandemic; 

6.	 assess all public health and clinical laboratory influenza diagnostic testing proficiency 

and adherence to biosafety containment and biomonitoring protocols at least annually; 

7.	 test the knowledge and competency of frontline clinicians and laboratory personnel with 

regard to: 

a.	 protocols for safe specimen collection and testing, 

b.	 the way in which and the person to whom a potential case of novel influenza 

should be reported, and 

c.	 mechanisms for submitting specimens to referral laboratories; and 

8.	 determine how hospitals and health care systems will use systems and communication 

tools to report information to public health and response partners with an emphasis on 

regional hospital coordination. 

Role of Clinical Laboratories in Public Health Preparedness and Response 

As of June 2007, there were 210 public health laboratories in the U.S.11 According to the 

Association of Public Health Laboratories, disease prevention, control, and surveillance should 

collectively represent a core function of State public health laboratories.12 13 However, privately 

owned clinical laboratories, which are not under the control of State public health laboratories, 

play a key role in States’ ability to perform these activities, especially surveillance. 

Clinical laboratories are often the first line of defense in a public health response because they 

perform diagnostic tests ordered by physicians and may be the first to identify the causes of 

illnesses in communities. However, not all clinical laboratories have the capacity to conduct 

initial screenings and refer suspicious specimens to a reference laboratory, usually the State 

public health laboratory, to confirm the presence of public health threats. Clinical laboratories 

that do have these capabilities are known as sentinel laboratories.14 

11 Clinical Laboratory Improvement Amendments (CLIA) Update, Division of Laboratory Services, Centers for Medicare &
 

Medicaid Services, Laboratories by Type of Facility, June 2007. Available online at 

http://www.cms.hhs.gov/CLIA/downloads/factype.pdf. Accessed September 17, 2007.
 12 “Core Functions and Capabilities of State Public Health Laboratories,” p. 6. Available online at 

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5114a1.htm. Accessed August 29, 2007.
 13 Public health surveillance is the ongoing collection, analysis, and interpretation of health data to improve health and safety.
 14 Forty-nine States use this definition of sentinel laboratory in the pandemic influenza context.
 
Page 4 – Dr. Julie L. Gerberding, M.D., M.P.H. 

Related Work 

OIG is conducting a study of laboratory preparedness for bioterrorism and other public health 

emergencies. We expect to issue a final report on those findings in early 2008. 

METHODOLOGY 

Scope 

We surveyed officials in all 50 States and the District of Columbia (hereafter referred to as 

States) about the extent to which they conducted the eight critical tasks for public health 

laboratory testing as required by the Guidance. Four of these critical tasks require coordination 

with clinical laboratories. We also asked the officials about public health and sentinel laboratory 

capability to subtype H5 influenza, as well as the type of preparedness exercises conducted by 

State public health laboratories (i.e., tabletop or full-scale). 

Data Collection 

We contacted the Cooperative Agreement coordinators in all States to inform them about our 

survey and to request the names of the most appropriate respondents. In most cases, we were 

referred to the State laboratory director or the bioterrorism coordinator. We sent an electronic 

mail survey to these public health laboratory officials identified by the Cooperative Agreement 

coordinator in each State and had a 100-percent response rate. 

Data Analysis 

We transferred State responses to our survey into an electronic database. Using the database, we 

determined the total number of States that reported performing each of the eight critical tasks. 

Where appropriate, we determined whether the State conducted an activity for both State public 

health and clinical laboratories. 

Limitations 

We asked State public health laboratory officials the extent to which they conducted the eight 

critical tasks for public health laboratory testing as required by the Guidance. However, 

responsibility for some of these tasks may fall under another State or non-State entity (e.g., the 

Office of Emergency Preparedness and Response or the College of American Pathologists, 

respectively). In addition, we did not collect supporting documentation to verify State responses 

to our survey, and we did not ask States about the performance measures associated with the 

eight critical tasks. Finally, our survey determined the extent to which State public health 

laboratories met Guidance requirements to include clinical laboratories in their preparedness 

planning. We did not directly survey clinical laboratory officials to determine whether they had 

performed pandemic influenza preparedness activities independent of the State public health 

laboratories. 

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. 
Page 5 – Dr. Julie L. Gerberding, M.D., M.P.H. 

RESULTS 

Critical task 1: All States reported that they conduct year-round influenza testing 

Year-round influenza testing can detect the emergence of influenza viruses outside the normal 

influenza season. This early detection may lead to a faster public health response to a potential 

pandemic influenza outbreak. All 51 States reported that their public health laboratories conduct 

year-round influenza testing. 

Critical task 2: All States reported the capability to perform PCR to detect and subtype 

influenza, but sentinel laboratory capability to subtype H5 influenza is limited or unknown 

The H5 strain of influenza infects birds but does not typically infect humans. However, it has 

caused human deaths and has the potential to evolve into a human pandemic strain. 

Although not specifically required by the Guidance, all 51 States reported public health 

laboratory capability to use PCR to subtype the H5 influenza strain. The H5 subtyping test is 

currently only available to public health laboratories. Consistent with this, 44 of 51 States 

reported that they have no sentinel laboratories with the capability to perform H5 influenza 

subtyping, and 4 States reported that they did not know whether sentinel laboratories in their 

State had H5 influenza subtyping capability. However, this capability may be necessary to meet 

increased testing needs during an H5 influenza pandemic. 

Critical task 3: States reported that they electronically exchange influenza data with CDC 

and public health laboratories to a greater extent than with clinical laboratories 

Public health officials often rely on patient-level data from clinical laboratories to determine an 

appropriate response to a public health event. Similarly, clinical laboratories often rely on State 

and national data from public health laboratories and CDC to determine appropriate laboratory 

testing. 

Almost 90 percent of States (45 of 51) reported exchanging electronic influenza data with CDC. 

Similarly, almost 90 percent of States (45 of 51) reported either that they exchanged electronic 

influenza data within the State public health laboratory system (24 of the 45 States) or that this 

requirement was not applicable (21 of the 45 States). For example, this requirement is not 

applicable in a State with only one public health laboratory. 

However, only 35 percent of States (18 of 51) reported electronic influenza data exchange 

between public health laboratories and clinical laboratories. 
 

 

 

Page 6 – Dr. Julie L. Gerberding, M.D., M.P.H. 

Table 1 shows the number of States reporting that the State public health laboratories exchanged 

electronic influenza data. 

Table 1 

Number of States Reporting That Public Health 

Laboratories Electronically Exchanged Influenza Data 

Entities With Which the Public 

Health Laboratories 

Electronically Exchanged 

Influenza Data 

Yes Not 

Applicable 

CDC 45 0 

Other State Public Health 

Laboratories 

24 21 

Clinical Laboratories 18 0 

Critical task 4: Over half of all States reported that they instituted surveillance for 

influenza-like illness among laboratory personnel at risk for atypical influenza 

Laboratory personnel who conduct influenza testing are at risk of developing illness from 

seasonal influenza, as well as atypical influenza present during a pandemic. The earlier illness is 

detected, the earlier the State may take action and attempt to contain its spread. Sixty-two 

percent of States (32 of 51) reported that they conduct surveillance for influenza-like illnesses 

among laboratory personnel at risk of developing atypical influenza. 

Critical task 5: States reported that they conduct pandemic influenza preparedness 

exercises in public health laboratories to a greater extent than in clinical laboratories 

Preparedness exercises present public health personnel hands-on practice of emergency plans 

and procedures. Exercises may also identify potential response weaknesses in advance of an 

actual event. 

Eighty-two percent of States (42 of 51) reported developing operational plans to augment public 

health laboratory capacity during an influenza pandemic. Forty-three percent of States (22 of 51) 

reported conducting tabletop exercises of their operational plans, and 20 percent of States (10 of 

51) reported conducting full-scale exercises.15 

In contrast, 55 percent of States (28 of 51) reported developing operational plans for clinical 

laboratory capacity. Thirty-one percent of States (16 of 51) reported conducting tabletop 

exercises of plans to meet the increased need for clinical laboratory testing capacity during an 

15 In a tabletop exercise, participants respond to a simulated emergency without time constraints from an office environment. 

Tabletop exercises are intended to evaluate plans and answer questions about coordination and assignments of responsibility. In 

a full-scale exercise, participants respond to a simulated emergency under time constraints conditions just as they would in a realworld event. Full-scale exercises are intended to identify problems that may arise in executing a plan. 
Page 7 – Dr. Julie L. Gerberding, M.D., M.P.H. 

influenza pandemic, and less than 10 percent of States (5 of 51) reported conducting full-scale 

exercises. 

Table 2 shows the number of States reporting that they have developed operational plans to 

augment laboratory capacity in an influenza pandemic and have tested those plans through 

tabletop or full-scale exercises. 

Table 2 

Number of States Reporting That They Have Developed and 

Tested Plans To Augment Laboratory Capacity 

Pandemic Influenza Preparedness 

Activity 

Public Health 

Laboratory 

Capacity 

Clinical 

Laboratory 

Capacity 

Developed operational plan 42 28 

Exercised operational plan – tabletop 22 16 

Exercised operational plan – full-scale 10 5 

Critical task 6: States reported that they conduct annual assessments of influenza-related 

practices in public health laboratories to a greater extent than in clinical laboratories 

Annual assessments of laboratory practices help to ensure that laboratory personnel are using the 

most current practices in responding to an influenza outbreak. 

Depending on the laboratory practice, 65 percent to 82 percent of States (33 to 42 States) 

reported that the State public health laboratories conduct annual assessments of influenza-related 

activities in public health laboratories. However, only 12 percent to 20 percent of States (6 to 

10 States) reported that the State public health laboratories conduct the same annual assessments 

in clinical laboratories. 

Table 3 shows specific influenza-related practices and the corresponding number of States that 

reported conducting at least annual assessments in public health and clinical laboratories. 

Table 3 

Number of States Reporting That the Public Health Laboratories 

Annually Assess Influenza-Related Practices 

Areas State Public Health Laboratories Assess 

Annually 

Public Health 

Laboratory 

Assessments 

Clinical 

Laboratory 

Assessments 

Influenza diagnostic testing proficiency 42 10 

Adherence to influenza biosafety containment 42 7 

Adherence to influenza biomonitoring protocols 33 6 
Page 8 – Dr. Julie L. Gerberding, M.D., M.P.H. 

Twenty-one States reported that they do not assess clinical laboratories on the activities specified 

in the Guidance because this function is performed by other organizations (e.g., the College of 

American Pathologists or the Centers for Medicare & Medicaid Services in its oversight of the 

Clinical Laboratory Improvement Act). 

Critical task 7: States reported that they conduct tests on pandemic influenza preparedness 

activities for frontline laboratory personnel to a greater extent than for frontline clinicians 

Frontline clinicians and laboratory personnel who perform diagnostic tests play a significant role 

in public health emergency response. They may be the first to identify and trigger a State’s 

response to illness in communities. 

Depending on the laboratory practice, 53 percent to 73 percent of States (27 to 37 States) 

reported that their public health laboratories test frontline laboratory personnel on pandemic 

influenza preparedness activities (e.g., protocols for safe specimen collection and testing and 

referring potential cases of novel influenza). 

Less than 25 percent of States (11 of 51) reported that their public health laboratories test 

clinicians on how to submit suspected influenza specimens to a testing laboratory. Even fewer 

States (7 of 51) reported that their public health laboratories test clinicians on the person they 

should contact when referring a potential case of novel influenza or on protocols for safe 

specimen collection or testing. 

Table 4 lists specific pandemic influenza preparedness activities, along with the number of States 

reporting that their public health laboratories test each activity for frontline laboratory personnel 

and clinicians. 

Table 4 

Number of States Reporting That the Public Health Laboratories Test 

Influenza Preparedness Activities for Laboratory Personnel and Clinicians 

Preparedness Activity Tested Laboratory 

Personnel 

Testing 

Clinician 

Testing 

Protocols for safe specimen collection 28 7 

Protocols for safe specimen testing 32 7 

How to refer a potential case of novel influenza 27 8 

Person to contact when referring a potential case 

of novel influenza 

29 7 

How to submit specimens to a referral laboratory 37 11 
Page 9 – Dr. Julie L. Gerberding, M.D., M.P.H. 

Two States reported that they do not test frontline laboratory personnel or clinicians because they 

receive pandemic influenza preparedness testing or training through a third party (e.g., the Health 

Resources and Services Administration or the State Office of Epidemiology). In addition, one 

State reported that because public health laboratory personnel are not responsible for collecting 

specimens or referring potential cases of novel influenza, they are not tested on these tasks. 

Critical task 8: Twenty-five percent of States reported that they determine how hospitals 

and health care systems would use pandemic influenza communication tools 

Accurate communication during a health event enables public health officials to determine the 

optimal course of action in responding to an event. States should formalize communication 

procedures in advance to avoid confusion and miscommunication during an actual event. 

Twenty-five percent of States (13 of 51) reported that their State public health laboratories have 

determined how hospitals and health care systems would use pandemic influenza communication 

tools to report information to public health and response partners during an event. Of these 

13 States, 6 further reported that their public health laboratories have determined how 

communication tools would be used for regional hospital coordination. 

Twenty-seven percent of States (14 of 51) reported that they have not determined how hospitals 

and health care systems would use communication tools because this function is carried out by 

other State entities (e.g., the Office of Public Health Emergency Preparedness or the Bureau of 

Epidemiology). 

CONCLUSION 

Pandemic influenza preparedness projects supported by Phase II Guidance funding should be 

completed in 3 years, ending in 2009. Most State public health laboratories reported that they 

have already performed some of the requirements specified by the Guidance. For example, all 

States reported that their public health laboratories performed the requirement for year-round 

influenza testing. In addition, over half of States reported instituting surveillance for influenzalike illness among laboratory personnel. Although not specifically required by the Guidance, all 

States also reported public health laboratory capability to subtype H5 influenza, but sentinel 

laboratory capability to subtype H5 influenza is limited or unknown. However, this capability 

may be necessary to meet increased testing needs during an H5 influenza pandemic. 

Our survey results demonstrate that opportunities exist to improve public health laboratory 

coordination with clinical laboratories. For the critical tasks involving both public health and 

clinical laboratories, States reported performing the required activities for public health 

laboratories to a greater extent than for clinical laboratories. 

Clinical laboratories will likely be among the first to detect an influenza outbreak because they 

perform diagnostic testing ordered by clinicians. Therefore, coordination between State public 
Page 10 – Dr. Julie L. Gerberding, M.D., M.P.H. 

health and clinical laboratory officials is critical to decrease the time needed to detect and report 

a pandemic influenza outbreak. 

If you have any questions about this memorandum report, please do not hesitate to contact me or 

one of your staff may contact Claire Barnard, Director of External Affairs, at (202) 205-9523 or 

through e-mail [Claire.Barnard@oig.hhs.gov]. To facilitate identification, please refer to 

memorandum report number OEI-04-07-00670 in all correspondence. 

cc: Rear Admiral W. Craig Vanderwagen, M.D. 

 Assistant Secretary for Preparedness and Response