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
 
Daniel R. Levinson~ t. ~
 
FROM:	 
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-Danflu
guidance.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 
Nations 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 Presidents 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  Yes  Not 
Health Laboratories  Applicable 
Electronically Exchanged 
Influenza Data 
CDC  45  0 
Other State Public Health  24  21 
Laboratories 
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 real-
world 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  Public Health  Clinical 
Activity  Laboratory  Laboratory 
Capacity  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  Public Health  Clinical 
Annually  Laboratory  Laboratory 
Assessments  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 States 
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  Clinician 
Personnel  Testing 
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  29  7 
of novel influenza 
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 influenza-
like 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