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A survey-based assessment of United States clinical laboratory response to the 2009 H1N1 influenza outbreak.

The recent outbreak of a novel strain of 2009 H1N1 influenza A has affected laboratories worldwide, with a potentially tremendous impact on the practice of clinical laboratory medicine in general and clinical microbiology and virology in particular. The recognition of this new strain of virus and its subsequent spread occurred rapidly and in many respects represents a case study of a newly emergent pathogen. Although the outbreak eventually turned out to be relatively mild, initially it was feared that this agent would represent a significant threat, resulting in considerable morbidity and mortality. As such, many of the issues that arose in the course of this outbreak and the subsequent response by the US health care system have relevance to future responses to emerging pathogens and threats to public health.

Numerous publications have now detailed various aspects of the outbreak. (1) The epidemiology of the infection, its potential genesis and mode of spread, and risk factors among the population for predicting susceptibility and outcome have all been explored. (1) In addition, there was a rapid response in the clinical diagnostic community to this challenge, and publications describing the evaluation of a broad range of diagnostic testing platforms and modalities (2-4) were produced in rapid succession. The diagnostic testing industry has been quick to respond with the production of new testing methods, particularly aimed at identifying the new strain of influenza and differentiating it from other previously circulating seasonal strains of the virus. (5)

From a public health perspective, the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia), the World Health Organization, and state and other public health laboratories responded rapidly to this perceived threat. Numerous announcements, guidelines, and recommendations were promulgated both by these public health care authorities and by others, including various national societies. Information was distributed both to the health care industry and to the general public through a wide variety of print and electronic outlets, as well as live video and teleconferences.

Numerous other aspects of the health care response included the availability and timeliness of confirmatory testing for 2009 H1N1 influenza by state and other public health laboratories, as well as elements of individual laboratory preparedness and response. (6-11) The latter included availability of personal protective equipment (PPE) and its appropriate use, use and availability of appropriate testing supplies, adequacy of staffing, and infrastructure requirements including laboratory space. The ability of laboratories to respond appropriately to this outbreak was a composite of all these factors and others. Limited data have been generated to measure the effectiveness of this response, as well as to identify factors that may have impaired the ability to deliver timely and accurate laboratory data in a safe and efficacious manner. In response to this need and in conjunction with the CDC, in August 2009, the College of American Pathologists (CAP; Northfield, Illinois) distributed a survey among laboratories participating in proficiency testing services to measure their response to the 2009 H1N1 influenza outbreak and to explore factors that may have affected their ability to respond in an optimal manner.

METHODS

Summary of Methods

A 24-question survey was developed to determine the current practices of clinical laboratories with respect to influenza testing; how clinical laboratories were affected by the 2009 H1N1 influenza outbreak in terms of safety, communication of results, testing volume, and resources; and whether changes in resource allocation or laboratory practice were anticipated in preparation for the 2009-2010 influenza season. Limited information was also collected regarding respondents and clinical practice settings. The survey was distributed by e-mail and made available for online data entry. The invitation e-mail was sent to 3828 eligible CAP customers, and participants were given 9 business days to enter their anonymous answers, after which time the Internet link was disabled and the study closed. Once study participants completed the questionnaire and submitted their responses online, the data were saved on a server and downloaded to a local computer at the CAP for data analysis.

Study Population

The study population consisted of clinical laboratories performing routine clinical diagnostic testing for respiratory viral pathogens. Surveys were sent to institutions enrolled in a minimum of 1 of the following CAP proficiency testing surveys: Virology Culture Survey (VR1); Virology Antigen Detection (DFA) Survey (VR2); Virology (Non-IF) Antigen Detection (VR4); Nucleic Acid Amplification, Viruses (ID1); Nucleic Acid Amplification, Respiratory (ID2); or Viral Antigen Detection (M21). An email was sent to CAP customers who were eligible to participate in the study. The e-mail, sent on August 11, 2009, invited laboratories to participate in the study and included a hyperlink that would lead them directly to the survey; the survey was available online until August 20, 2009. A study participant was defined as a clinical laboratory recruited by e-mail invitation that completed the online survey.

Survey Composition

Seasonal Influenza Testing and Laboratory Safety Practices.--Participants were asked to specify methods routinely used for the detection of seasonal influenza virus. Stratified by methodology, further details were asked regarding use of PPE and typical timeframes for reporting of diagnostic testing results. The latter were defined as the period from when specimens were received in the laboratory until when results were reported.

Changes in Testing and Safety Practices Related to the Recent Outbreak of 2009 H1N1 Influenza.--Laboratories were asked for details specific to detection and identification of the 2009 H1N1 influenza virus. Testing methodologies and information on the use of PPE were requested, in addition to any restrictions on test availability in response to the outbreak. Changes in laboratory testing volume were examined, as were methods for subtyping of influenza A strains, when identified. As the latter was often accomplished by sending samples to public health laboratories, the effectiveness of those services was also queried.

Limitations Experienced During the 2009 H1N1 Influenza Pandemic and Effects on Result Reporting.--A critical component of the survey was an assessment of limitations faced in responding to the outbreak. Questions related to these issues attempted to gauge satisfaction with and clarity of information disseminated by public health authorities and others. The survey also attempted to assess the ability of individual laboratories to provide timely results for influenza testing while maintaining other routine laboratory functions. Participants were asked whether they had experienced shortages in PPE and influenza testing materials, had seen limitations related to increased volume to staffing ratios, or had experienced other effects secondary to the outbreak that appeared detrimental to the laboratory's ability to maintain a consistently high standard of care.

Future Plans for Change in Response to the 2009 H1N1 Influenza Outbreak.--The last portion of the questionnaire focused on changes that were anticipated by laboratories in response to the outbreak and in preparation for the current (2009-2010) influenza season.

Statistical Analysis

Frequencies and proportions were used to analyze answers to the survey. The total number of answers to some questions varied depending on the nature of the question and on the type of institution answering, as well as on the types of tests offered at that institution.

RESULTS

A total of 931 (24.3%) of eligible clinical laboratories completed the online survey (Table 1). A broad range of clinical practice settings were represented, including 694 hospitals or medical centers (74.5%), 52 clinics (5.6%), 40 physician office laboratories (4.3%), 37 commercial or independent reference laboratories (4%), 36 core laboratories for multiple hospitals (3.9%), and 72 other institutions (7.7%). Most questionnaires were completed by laboratory managers, section heads, or supervisors (nearly 80%), with the balance filled out primarily by laboratory directors and laboratory technologists/technicians.

Routine Influenza Testing Methods

Most participants (96.8%) reported the routine use of at least 1 method for detection of influenza virus, with only 30 institutions not performing such testing in-house (3.2%) (Table 2). Assays that differentiate between influenza types A and B were performed by 861 laboratories, 36 did not differentiate influenza types, and 4 performed testing for influenza A only. By far, rapid antigen detection was the most commonly used diagnostic method, with 847 laboratories (91%) reporting its use. Roughly equal proportions of responding laboratories used tube culture (5.9%), shell vial culture (8.4%), fluorescent antibody detection (6.4%), and molecular methods (7.8%). Of those using rapid antigen testing, 87.1% reported using it as a stand-alone method, while the remaining 12.9% of the participants used 1 or more additional methods. In comparison, 80.8% of those using molecular diagnostic tests also used 1 or more nonmolecular methods. The use of PPE appeared largely appropriate for the methods used (Table 3).

Testing Turn-Around Time, Volume, and Resources for Routine Testing

As expected, rapid antigen detection was reported to have the most rapid turn-around time for result reporting (Figure 1). Excluding unsure responses (0.2%), 97.5% of the sites using this methodology reported a turn-around time of 2 hours or less, with the balance reporting in 3 to 24 hours. Turn-around time was defined as the period from when specimens were received in the laboratory until when results were reported. There was more uncertainty concerning the reporting times for other methods; 35% to 50% of respondents were not able to provide data on turn-around time for these tests. Among those who did provide such data, turn-around time patterns were consistent with established norms and with the relative time each methodology typically requires for completion. Fluorescent antibody test results were most often reported by the 24-hour mark (84.2%), shell vial cultures within 7 days (97.5%), and tube cultures within 2 weeks (92.1%). The results of molecular testing were reported across a wide range of time, with 58.8% of laboratories reporting in the first 24 hours and the remainder of reporting distributed during the 2- to 7-day and 8- to 14-day timeframes (25.8% reported between 2 and 3 days and 13.4% between 4 and 7 days).

Postoutbreak Testing Methodologies and Biosafety Practices

As shown in Table 4, most laboratories continued to use their previous diagnostic testing methods after the onset of the influenza outbreak. However, perhaps the most significant finding in this respect was the marked increase in the use of molecular testing. The data indicate a more than 2-fold increase in the use of this modality in response to the epidemic; 54.9% of those using molecular methods stated that they had been implemented for this reason.

A substantial proportion of respondents reported an increased use of PPE. The nature of such changes in practice varied markedly among laboratories, but many indicated the increased use of biosafety cabinets and respirators (such as the N95 respirator), and 6.5% implemented full biosafety level 3 procedures for influenza testing. More than half of laboratories (61.2%) appropriately cautioned physicians that negative results of rapid antigen, fluorescent antibody, or culture-based testing might represent a false negative and should not be relied on to rule out infection with 2009 H1N1 influenza. A somewhat higher proportion of laboratories (72.0%) cautioned physicians that positive influenza A results were not specific for infection with 2009 H1N1 influenza in the absence of confirmation by a subtyping assay.

As seen in Table 2, most respondents (83.8%) neither used nor planned to implement an influenza subtyping assay (for differentiating H or N subtypes). Only 8.4% of institutions reported using a subtyping assay at the time of the survey; about the same proportion of laboratories testing for influenza (7.8%) were planning to implement a subtyping assay within 12 months. Most (77.7%) sent specimens to state or other public health laboratories for subtyping, and 45.1% noted at least some delay in processing samples referred to those public health laboratories. Overall, confirmatory testing results took more than 5 days to report in 38.2% of cases and were reported within 2 days or less by only 22.5% of respondents (Figure 2). Notably, of those performing confirmatory testing in-house, most (71.4%) reported results in 2 days or less.

Influenza Testing Volume and Resources

Testing volumes more than doubled in 15.6% of laboratories, increased by at least 50% in 29.5% of laboratories, and by at least 25% in 47.6%; 5.8% were unsure of volume increases. An increase between 1% and 24% was experienced by 356 institutions (39.5%) and no increase at all by 64 respondents (7.1%; Table 5). Most institutions performed all tests ordered by clinicians; restrictions were not implemented to testing inpatient (71.1%) or outpatient (72.6%) samples. As a result of increased test volume, a quarter or more of respondents experienced shortages of collection devices, reagents, or kits for influenza testing. Absenteeism was limited, and only 8.9% reported an increase due to employees or their families being diagnosed with influenza. However, 145 sites (16.1%) experienced staffing shortages due to the increased testing volume. Only a minority were able to address this issue. Staffing increases (combining staff reassignments and new hires of permanent or temporary staff) were reported by 57 respondents (6.4%). Despite these challenges and others, most institutions (89.6%) felt there was no negative impact on overall patient care due to the unexpectedly heavy volume of influenza test requests.

[FIGURE 1 OMITTED]

Most institutions participating in the survey were planning to increase resources in preparation for the 2009-2010 influenza season; only 12.5% of institutions were not planning to increase resources. Most increases were anticipated in the stocked inventory of reagents or kits for influenza testing (84.6%) and PPE (42.3%). One hundred sixteen respondents (12.9%) reported that their budgets would be increased in preparation for the 20092010 influenza season, whereas only 9% were planning on increasing their staff levels (Figure 3).

Public Health Issues Related to the 2009 H1N1 Outbreak

When participants were asked if they received sufficient information and updates from reputable or authoritative sources, responses were overwhelmingly (95.7%) favorable. This information was provided by a spectrum of organizations (Table 6), with the CDC and state or public health laboratories both relied on by more than 90% of respondents. Perhaps as a byproduct of the number of sources of information, more than 40% reported some confusion between media messages and information disseminated by authoritative sources. Several respondents commented on frequent changes in recommendations; lack of agreement among recommendations at the local, state, and national levels; and excessive "alarmist" media coverage as problematic issues. As previously noted, delays in confirmatory testing by state and public health laboratories represented an additional concern.

[FIGURE 2 OMITTED]

COMMENT

The recent pandemic outbreak of 2009 H1N1 influenza had ramifications throughout the US and worldwide health care systems. Numerous articles have now been published regarding the viral etiology of the outbreak, with several studies evaluating accuracy of available testing modalities for detection and characterization of the virus. Much less has been written regarding the response of health care systems to this challenge. A few have looked in great depth at the pandemic response of individual health care systems or hospitals, (12) and others have made some assessment of public health care effectiveness. (6,8,10,11,13,14) Overall hospital preparedness has also been reviewed. (15,16) However, to our knowledge the present study is the only comprehensive evaluation regarding the nature and effectiveness of laboratory actions across the entire spectrum of health care practice settings and throughout the United States.

Findings here suggest that the extensive preparations for pandemic influenza, which have taken place during the last several years, have served the public well. Although the present outbreak may not have reached the level of severity initially feared from a potential outbreak of avian influenza, the challenge to clinical and microbiology testing laboratories was nonetheless significant.

[FIGURE 3 OMITTED]

The survey results reveal a snapshot of national influenza testing practices, overwhelmingly dominated by rapid, enzyme immunoassay-based antigen detection systems, with comparatively small percentages of laboratories engaging in culture, fluorescent antibody detection, or molecular testing modalities. This preponderance of rapid antigen testing is neither surprising nor optimal in diagnostic efficacy. Numerous studies have detailed the variable accuracy of such tests for the diagnosis of seasonal influenza. (2,18,19) More recently, the limited sensitivity of rapid diagnostic methods for 2009 H1N1 influenza has been demonstrated, (2-4) and others have questioned the specificity and positive predictive value of such tests. With such limited performance characteristics, the overall utility of continuing to use such methods must be questioned. If such rapid antigen tests are used as a first-line diagnostic modality, it is recommended that negative results be confirmed by a more sensitive method such as culture or polymerase chain reaction. (2) A disclaimer could be attached to all reports indicating that negative result should not be relied on to rule out infection with 2009 H1N1 influenza. This survey shows that only 61.2% of participating laboratories applied such a cautionary message.

At the other extreme, for diagnostic efficacy, molecular diagnostic tests were reportedly used by less than 10% of participating institutions. A large percentage of these implemented molecular methods in response to the present outbreak and a further substantial number planned to do so in the coming months. Molecular methods outperform both antigen and culture-based techniques for the detection of seasonal influenza and have been regarded as a reference standard for the diagnosis of 2009 H1N1 influenza. Increasing adaptation of such techniques is a promising finding in this survey. The increasingly rapid and automated molecular detection methods that are commercially available may improve laboratory surge capacity, as staffing and hands-on technologist requirements may no longer increase proportionately to increases in test volume when using such automated systems. Another potential advantage of molecular-based technologies is their ability in some cases to provide viral subtyping information. Subtypes of influenza viruses may be a useful surrogate marker to help predict susceptibility or resistance to commonly used antiviral agents such as oseltamivir. Subtyping information may also be useful for implementing infection control practices because recommendations may vary depending on viral subtype. Although only a small percentage of laboratories indicated an in-house ability to perform subtyping, this proportion can be expected to grow over time.

The high proportion of laboratories presently using diagnostic methods that do not require viral cultivation reduces the need for high-level biosafety practices. Most laboratories appear to engage in biosafety practices and the use of PPE appropriate for the diagnostic methods used in their individual practice settings. Numerous laboratories reported an increase in the use of PPE and adaptation of a higher overall level of biosafety practices. Although a few implemented full biosafety level 3 practices, many changes were limited to increased use of gloves and biosafety cabinets for handling and testing of clinical specimens.

Those improvements in safety practices were made more challenging by substantial increases in testing volume experienced by most survey respondents. The ability of laboratories to maintain a high standard of patient care in the presence of, in some cases, a more than 100% increase over usual influenza testing volume is testament to the preparedness measures that had been taken previously and to the level of training and professionalism among laboratorians in this country. Increased testing levels resulted in shortages of both materials and staff. Although some centers were able to either add or temporarily reassign personnel to help manage the increased demand, this represented a minority of laboratories. These resource shortfalls may serve as valuable lessons for future preparedness. It is noteworthy that although most laboratories planned to increase their inventory of kits and reagents for the coming "regular" flu season and many planned to increase their inventory of PPE, a relatively low percentage saw an ability to increase either their budget or staffing levels. Although the increasing use of molecular technologies may reflect improved diagnostic capabilities, such technology is costly and its implementation without accompanying increases in resources may prove challenging for many laboratories. The ability of laboratories to respond to this pandemic has represented a dynamic and shifting balance, as costs surged due to increasing demand during the initial outbreak but have subsequently dropped due both to fluctuating disease prevalence and to more restrictive testing guidelines, as recommended more recently by the CDC.20 Although such restrictions were not in place at the time of this survey, the relatively low number of respondents indicating any limitations on testing illustrates the importance in staying abreast of public health recommendations. Increased reliance on clinical diagnosis in geographic areas with documented circulating influenza could substantially reduce laboratory use and have significant budgetary impact.

Lessons were also learned on the public health care front. Although not the primary focus of this study, it was clear that most centers relied on the CDC and other recognized authorities for information and guidance related to the outbreak. Most were satisfied with the updates that they received from these sources, but some reported confusion regarding the information provided. The sense of too much information from too many sources may have contributed to this issue and may suggest that further coordination between various authorities would be beneficial in the future and may reduce unnecessary duplication of efforts by various organizations. The other primary role of public health laboratories related to confirmatory testing. Again, mixed results were seen here, with just under half of respondents reporting delays in such testing. This may well have related to reported delays in distribution of testing methodologies and supplies to public health laboratories and to the initial surge in requests for such testing. The latter resulted in an early backlog of cases, as testing was being brought online and as additional testing capacity was developed.

This study had several limitations. It did not provide detailed data on the effectiveness of the public health care response because its primary goal was to record a representative picture of how typical institutions responded to the sudden and severe challenges posed by this outbreak. The survey was also limited in its scope and detail by a desire to keep the number of questions posed to a minimum, so as to encourage participation. Although the nearly 25% response rate was as good as might be expected for a survey of this nature, it is impossible to gauge whether results were biased based on those who chose to participate. In addition, although questions were reviewed by numerous individuals before distribution, some inconsistencies of interpretation by those answering the survey was inevitable. Finally, depending on the individual in any given institution who entered the responses, there may have been some variation in both subjective and objective observations, most notably in cases in which a response of "uncertain" was selected. Many of the findings here, however, appear consistent with anecdotal reports and several are so striking in the preponderance of responses that they appear likely to be accurate.

The results of this survey provide perhaps one of the most comprehensive views available of clinical laboratory response in the United States to the recent outbreak of 2009 H1N1 influenza. They also may provide a surrogate for more generally examining clinical laboratory (particularly microbiology) emergency preparedness. The insights gained from this experience should be invaluable in preparing both in the near-term, for continuation of the pandemic, and in the long-term, for the inevitable emergence of other public health threats. The clinical microbiology laboratories represented in this study are a critical component of national readiness, and the ability to objectively demonstrate both the strengths and weaknesses of their responses is essential in future planning efforts.

References

(1.) Sullivan SJ, Jacobson RM, Dowdle WR, Poland GA. 2009 H1N1 influenza. Mayo Clin Proc. 2010;85(1):64-76.

(2.) Evaluation of rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus--United States, 2009. MMWR Morb Mortal Wkly Rep. 2009;58(30):826-829.

(3.) Cheng PK, Wong KK, Mak GC, et al. Performance of laboratory diagnostics for the detection of influenza A(H1N1)v virus as correlated with the time after symptom onset and viral load. J Clin Virol. 2010;47(2):182-185.

(4.) Ginocchio CC, Zhang F, Manji R, et al. Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak. J Clin Virol. 2009;45(3):191-195.

(5.) Medical devices and flu emergencies: emergency use authorizations for medical devices used in flu diagnosis and protection 2009 H1N1 flu virus (swine flu). US Food and Drug Administration. January 21, 2010. http://www.fda.gov/ MedicalDevices/Safety/EmergencySituations/ucm161496.htm. Accessed February 8, 2010.

(6.) Bell DM, Weisfuse IB, Hernandez-Avila M, Del RC, Bustamante X, Rodier G. Pandemic influenza as 21st century urban public health crisis. Emerg Infect Dis. 2009;15(12):1963-1969.

(7.) Carlson AL, Perl TM. Responding to H1N1 in health care institutions: is the glass half full or half empty? Clin Infect Dis. 2010;50(4):528-530.

(8.) Garon JEYSMS. The novelH1N1 outbreak: lessons learned. Lab Med. 2010; 41(1):12-15.

(9.) Meltzer MI, McNeill KM, Miller JD. Laboratory surge capacity and pandemic influenza. Emerg Infect Dis. 2010;16(1):147-148.

(10.) Oshitani H, Kamigaki T, Suzuki A. Major issues and challenges of influenza pandemic preparedness in developing countries. Emerg Infect Dis. 2008;14(6):875-880.

(11.) Spika JS, Butler-Jones D. Pandemic influenza (H1N1): our Canadian response. Can J Public Health. 2009;100(5):337-339.

(12.) Crawford JM, Stallone R, Zhang F, et al. Laboratory surge response to pandemic (H1N1) 2009 outbreak, New York City metropolitan area, USA. Emerg Infect Dis. 2010;16(1):8-13.

(13.) Global influenza surveillance network: laboratory surveillance and response to pandemic H1N1 2009. Wkly Epidemiol Rec. 2009;84(36):361-365.

(14.) Ringel JS, Trentacost E, Lurie N. How well did health departments communicate about risk at the start of the swine flu epidemic in 2009? Health Aff (Millwood). 2009;28(4):w743-w750.

(15.) Lautenbach E, Saint S, Henderson DK, Harris AD. Initial response of health care institutions to emergence of H1N1 influenza: experiences, obstacles, and perceived future needs. Clin Infect Dis. 2010;50(4):523-527.

(16.) Li X, Huang J, Zhang H. An analysis of hospital preparedness capacity for public health emergency in four regions of China: Beijing, Shandong, Guangxi, and Hainan. BMC Public Health. 2008;8:319.

(17.) Hurt AC, Alexander R, Hibbert J, Deed N, Barr IG. Performance of six influenza rapid tests in detecting human influenza in clinical specimens. JClin Virol. 2007;39(2):132-135.

(18.) Rahman M, Kieke BA, Vandermause MF, Mitchell PD, Greenlee RT, Belongia EA. Performance of Directigen flu A+B enzyme immunoassay and direct fluorescent assay for detection of influenza infection during the 2004-2005 season. Diagn Microbiol Infect Dis. 2007;58(4):413-418.

(19.) Rahman M, Vandermause MF, Kieke BA, Belongia EA. Performance of Binax NOW Flu A and B and direct fluorescent assay in comparison with a composite of viral culture or reverse transcription polymerase chain reaction for detection of influenza infection during the 2006 to 2007 season. Diagn Microbiol Infect Dis. 2008;62(2):162-166.

(20.) Interim recommendations for clinical use of influenza diagnostic tests during the 2009-10 influenza season. Centers for Disease Control and Prevention. September 29, 2009. http://cdc.gov/h1n1flu/guidance/diagnostic_ tests.htm. Accessed April 19, 2010.

Randall T. Hayden, MD; Megan T. Wick, MT(ASCP); Alicia B. Rodriguez, MS; Angela M. Caliendo, MD, PhD; Michael J. Mitchell, MD; Christine C. Ginocchio, PhD, MT(ASCP); for the Microbiology Resource Committee of the College of American Pathologists

Randall T. Hayden, MD; Megan T. Wick, MT(ASCP); Alicia B. Rodriguez, MS; Angela M. Caliendo, MD, PhD; Michael J. Mitchell, MD; Christine C. Ginocchio, PhD, MT(ASCP); for the Microbiology Resource Committee of the College of American Pathologists

Accepted for publication May 24, 2010.

From the Department of Pathology, St Jude Children's Research Hospital, Memphis Tennessee (Dr Hayden and Ms Rodriguez);the College of American Pathologists, Northfield, Illinois (Ms Wick); the Department of Pathology and Laboratory Medicine, Emory University Hospital, Atlanta, Georgia (Dr Caliendo); Laboratory, UMass Memorial Hospital Laboratories, Worcester, Massachusetts (Dr Mitchell); and the Division of Infectious Disease Diagnostics, North Shore-LIJ Health System Laboratories, Lake Success, New York (Dr Ginocchio).

The authors have no relevant financial interest in the products or companies described in this article.

Reprints: Randall T. Hayden, MD, Department of Pathology, St Jude Children's Research Hospital, 332 N Lauderdale St, Room C5033, Mailstop #250, Memphis, TN 38105-2794 (e-mail: Randall.Hayden@ stjude.org).
Table 1. Respondent Characteristics (a)

 Frequency,
Characteristic No. (%)

Institution

Hospital/medical center
< 100 beds 225 (24.2)
100-300 beds 301 (32.3)
301-500 beds 117 (12.6)
> 500 beds 51 (5.5)
Clinic 52 (5.6)
Physician office laboratory
1 Physician 2 (0.2)
2-5 Physicians 12 (1.3)
>5 Physicians 26 (2.8)
Commercial/independent reference laboratory 37 (4)
Core laboratory for multiple hospitals 36 (3.9)
Other institution 72 (7.7)

Responder position

Laboratory director (MD or PhD) 64 (6.9)
Laboratory manager/supervisor 653 (70.1)
Laboratory technologist/technician 62 (6.7)
Section head/supervisor 91 (9.8)
Quality assurance/control manager/director 30 (3.2)
Nurse practitioner 0
Physician assistant 0
Other 31 (3.3)

(a) N = 931.

Table 2. Testing Methods Used for Influenza by
Responding Institutions

 Frequency,
Description No./Total No. (%)

Routine testing
Rapid antigen kit 847/931 (91)
Fluorescent antibody--excluding
culture confirmation 58/931 (6.2)
Culture methods
Shell vial/cluster tray culture
(individual cell lines) 19/931 (2)
Shell vial/cluster tray culture
(hybrid cell lines) 60/931 (6.4)
Tube culture 55/931 (5.9)
Molecular amplification 73/931 (7.8)
Other methods 24/931 (2.6)
Influenza testing not done 30/931 (3.2)

Use of subtyping assay

Currently using 76/901 (8.4)
Plan to use within 3 months 33/901 (3.7)
Plan to use within 6 months 18/901 (2)
Plan to use within 12 months 19/901 (2.1)
Does not or is not planning to use 755/901 (83.8)

Table 3. Protective Equipment Used for Influenza Testing

 Method

 Rapid Antigen Fluorescent
Safety Measure Kit, No. (%) Antibody, No. (%)

Responding institutions 846 72

Gloves 840 (99.3) 71 (98.6)
Laboratory coat 761 (90) 66 (91.7)
Closed front gown 286 (33.8) 28 (38.9)
Eye protection 199 (23.5) 23 (31.9)

Face mask (surgical,
dental, medical procedure, 89 (10.5) 13 (18.1)
or isolation masks)
Fit-tested N95 respirator 66 (7.8) 10 (13.9)
Shoe covers 15 (1.8) 4 (5.6)
Biosafety cabinet 455 (53.8) 63 (87.5)
Other 1 (0.1) 3 (4.2)

 Method

Safety Measure Culture, Molecular,
 No. (%) No. (%)

Responding institutions 113 73

Gloves 111 (98.2) 70 (95.9)
Laboratory coat 99 (87.6) 59 (80.8)
Closed front gown 53 (46.9) 39 (53.4)
Eye protection 38 (33.6) 21 (28.8)

Face mask (surgical,
dental, medical procedure, 15 (13.3) 11 (15.1)
or isolation masks)
Fit-tested N95 respirator 21 (18.6) 19 (26)
Shoe covers 9 (8) 8 (11)
Biosafety cabinet 106 (93.8) 67 (91.8)
Other 3 (2.7) 0

Table 4. Changes Implemented to Methodologies Subsequent to
Influenza A Pandemic (H1N1) 2009 Outbreak

 Method

 Rapid Antigen Fluorescent
Change Kit, No. (%) Antibody, No. (%)

Responding institutions 847 71
Change in methodology
Continued using this method 749 (88.4) 55 (77.5)
Discontinued using this method 26 (3.1) 6 (8.5)
Continued using method, changed
manufacturers 50 (5.9) 1 (1.4)

Methods were revalidated to verify
detection of 2009 H1N1 influenza 30 (3.5) 5 (7)

New method verified and implemented
specifically for 2009 H1N1
influenza detection 11 (1.3) 0

Changed methods only for samples
from patients identified as "at
risk" for 2009 H1N1 influenza 39 (4.6) 13 (18.3)

 Method

Change Culture, Molecular,
 No. (%) No. (%)

Responding institutions 107 91
Change in methodology
Continued using this method 91 (85) 36 (39.6)
Discontinued using this method 6 (5.6) 0
Continued using method, changed
manufacturers 1 (0.9) 1 (1.1)

Methods were revalidated to verify
detection of 2009 H1N1 influenza 6 (5.6) 21 (23.1)

New method verified and implemented
specifically for 2009 H1N1
influenza detection 0 50 (54.9)

Changed methods only for samples
from patients identified as "at
risk" for 2009 H1N1 influenza 15 (14) 17 (18.7)

Table 5. Testing Volume and Resources
During Outbreak (a)

Measure Frequency,
 No. (%)
Increased testing volume

0% 64 (7.1)
1%-24% 356 (39.5)
25%-49% 163 (18.1)
50%-100% 125 (13.9)
.100% 141 (15.6)
Unsure 52 (5.8)

Restrictions to influenza patient testing

Inpatient
No restrictions 641 (71.1)
Only patients who fulfill risk factors (b) 154 (17.1)
were tested

Other 106 (11.8)

Outpatient
No restrictions 654 (72.6)
Only patients who fulfill risk factors (b) 145 (16.1)
were tested
Only patients being admitted were tested 29 (3.2)

Other 73 (8.1)

Increased staffing

No increase 823 (91.3)
Reassignment of staff
Staff from other areas 44 (4.9)
Research staff to clinical areas 1 (0.1)
Hired staff
Temporary 5 (0.6)
Additional permanent 7 (0.8)

Other 21 (2.3)

(a) N = 901.

(b) Risk factors as defined by public health authorities.

Table 6. Sources of Information Most Relied on
by Respondents (a)

 Frequency,
Source No. (%)

State or public health laboratory 852 (91.7)
Centers for Disease Control and Prevention (CDC) 838 (90.2)
College of American Pathologists (CAP) 353 (38.0)
World Health Organization (WHO) 267 (28.7)
American Society for Clinical Pathology (ASCP) 237 (25.5)
Local government 210 (22.6)
American Society of Microbiology (ASM) 209 (22.5)
Infectious Diseases Society of America (IDSA) 77 (8.3)
Other 75 (8.1)

(a) N = 929.
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Title Annotation:CAP Laboratory Improvement Programs
Author:Hayden, Randall T.; Wick, Megan T.; Rodriguez, Alicia B.; Caliendo, Angela M.; Mitchell, Michael J.;
Publication:Archives of Pathology & Laboratory Medicine
Date:Nov 1, 2010
Words:5579
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