Origins and Development of the National Laboratory System for Public Health Testing

SYNOPSIS

Although not recognized as such, a National Laboratory System (NLS) has existed since the inception of public health laboratory (PHL) testing more than a century ago. The NLS has always relied upon the participation of clinical laboratories, both to report test results that represent public health threats and to submit specimens and isolates to PHLs for additional or confirmatory testing. Historically, a number of factors have hindered the strengthening of the relationships between clinical laboratories and PHLs, but the reality of bioterrorism and subsequent focus on strengthening public-private relationships has stimulated the development of a more robust NLS.

Since 2002, there has been substantial strengthening of the NLS through the sharing of lessons learned from several demonstration projects. There is a growing emphasis on defining critical elements of the NLS, including the State Public Health Laboratory System (SPH Laboratory System) and the functions of the Laboratory Program Advisor, a position that every state should have at the center of its laboratory system's capacity-building. Additional strengthening of the NLS is occurring through (1) national biennial measurement of state PHLs' abilities to meet the Core Functions and Capabilities of State PHLs, (2) the new Laboratory System Improvement Program (L-SIP) for the SPH Laboratory System, and (3) sharing ideas to integrate and improve the SPH Laboratory System (e.g., using the L-SIP Online Resource Center). Public health emergencies, such as the recent H1N1 epidemic, illustrate and reinforce the need for a strong NLS within which federal, public health, and clinical (i.e., hospital and private reference) laboratories function in close collaboration.

The concept of a National Laboratory System (NLS) may have different meanings to different individuals, and the full scope of what the modern NLS should be remains to be clearly articulated. However, there is agreement that in its current form, the NLS is a largely voluntary system within which information and specimens are shared among private clinical laboratories, their state public health laboratories (PHLs), and, ultimately, the Centers for Disease Control and Prevention (CDC) (Figure 1). Ideally, there would be 100% reporting of all public health threats, but a recent report found that the overall reporting rate was only 49% for the critical diseases studied.¹ Despite state laws that require public health testing and reporting, and public perceptions to the contrary, the reality is that the system is essentially voluntary.

Figure 1.

Venn diagram used since 2000 to promote the National Laboratory System and explain the flow of data and specimens/isolates when the system is functioning optimally

In its current form, the NLS is neither a rigorously controlled nor sufficiently funded system. The NLS is more a collaborative community of clinical laboratories, state PHLs, and many individual partners who initiate tests and/or use test results. Further, the NLS is focused less on national (federal) testing, but more on state-based public health testing. As a collaborative system, the NLS includes the nurses, clinicians, and public health workers who order and use tests that have public health implications, as well as the city, local, state, and federal epidemiologists who are end users of the data. Because the bulk of public health testing services are delivered locally, the NLS can be viewed as an interactive network including a State Public Health Laboratory System (SPH Laboratory System) and a local public health laboratory system.

The NLS really began with PHL testing, which initially focused on identifying pathogens in water, milk, and food, but soon evolved to focus on testing clinical specimens for clinical diagnoses. Therefore, initially public health testing was synonymous with clinical testing because some clinical infectious disease testing could only be done in PHLs. During the second half of the 19th century, Louis Pasteur established a basis for the germ theory,² and Robert Koch definitively demonstrated the existence of Bacillus anthracis microorganisms and their link to disease.³ However, the realization that germs caused disease was insufficient for diagnosis and treatment, and the necessary equipment and expertise were scarce. Initially, clinical and environmental microbiologic testing was done in municipal PHLs. By the 1890s, as state and local PHLs became established,⁴ there was close collaboration between the PHLs and hospitals, not only by provision of clinical laboratory testing services to support physicians,⁵ but also through primary research and development of diagnostic tests. By the 1940s, Joseph Mountin would cite the provision of otherwise unavailable diagnostic services to physicians and hospital staff as a primary reason why PHLs were maintained by the state.⁶

Despite their reliance on clinical testing provided by PHLs, some physicians felt that PHLs encroached on their role as the primary diagnostician.⁷ Another inherent problem confronting physicians was the geographic separation between clinical laboratories and PHLs that tended to impede communication and cause lengthy testing turnaround times.

From the 1950s to the 1970s, as medical technology schools flourished, as diagnostic equipment and reagents became widely available,⁸ and as testing practices became more standardized,⁹ hospitals became self-sufficient for most clinical laboratory diagnostics. PHLs increasingly focused on more esoteric testing, which had important public health implications but did not impact patient diagnosis and treatment. PHLs were increasingly perceived as irrelevant to the clinical mission. This period established a lasting impediment to collaboration between PHLs and clinical laboratories: their fundamental missions (population health vs. patient-centric medicine) were perceived as mutually exclusive domains.

From the 1980s through the end of the century, a recurring theme was the reduction of the expense of providing public health testing through privatization.¹⁰ Thus, public health testing was sometimes viewed as a commodity rather than an integrated part of a larger systems approach. Newborn screening is perhaps the most compelling example of the turmoil caused by efforts to privatize public health testing because of the efforts made by private commercial concerns and the pushback exerted by public health systems.^11,12 As a relatively high-volume market, newborn screening is appealing for commercial reasons, yet it has compelling public health implications and there are programmatic interests that have a stake in keeping it under the purview of the PHLs. This era also saw decreasing funding for some state PHLs, various experiments to charge for patient testing (“fee for service”), discussions of regionalization of testing previously provided by individual states,¹³ and the problems of failures by large out-of-state commercial reference laboratories to report a notifiable disease to the patient's home state.¹⁴

A more recent problem is the proliferation of various non-culture diagnostic tests (e.g., for Shiga toxin-producing Escherichia coli), which are effective and expedient for patient treatment, but obviate the need for the culturing of isolates that are essential for identifying common source outbreaks.¹⁵ While clinical staff at private laboratories were increasingly unavailable to support public health efforts,¹⁶ PHLs likewise had insufficient staff to establish rapport with clinical laboratories, and may have perceived little benefit from doing so. There were some articulate advocates for PHLs at this time,^17,18 but for the most part, their message did not reach the clinical laboratory community. By the turn of the 21st century, there appeared to be increasingly little common ground for clinical laboratories and PHLs.

RECENT PROGRESS TO DEFINE AND NURTURE THE NLS

Many would identify the modern foundation of the NLS concept as having been laid in 1996 during the nationally broadcast “Partners for the Future” program jointly sponsored by the Association of Public Health Laboratories (APHL; then called the Association of State and Territorial Public Health Laboratories) and CDC. This endeavor brought together representatives from public health, educators, and clinical laboratory organizations with leaders from CDC and APHL to discuss how laboratory services in support of public health should be coordinated through effective partnerships. Materials were distributed to each state PHL, and these were shared with partners representing the field of epidemiology and clinical and environmental laboratories. Presentations and panel discussions were broadcast live to downlink sites in all states. In each state, there was at least one location where the respective state PHL representatives and their partners could hear the presentations and thereafter participate in a dialogue about the advantages of partnering. As a result, numerous lasting state- and local-level partnerships were created, paving the way toward a systems approach to public health services.

Perhaps no single document proved as useful to advancing the NLS as did the Core Functions and Capabilities of State Public Health Laboratories (hereafter, Core Functions), which were first published as an APHL white paper¹⁹ in 2000 and then published in Morbidity and Mortality Recommendations and Reports in 2002.²⁰ Virtually all 11 Core Functions depend upon sustained partnerships outside the state PHL: (1) disease prevention, control, and surveillance; (2) integrated data management; (3) reference and specialized testing; (4) environmental health and protection; (5) food safety; (6) laboratory improvement and regulation; (7) policy development; (8) emergency response; (9) public health-related research; (10) training and education; and (11) partnerships and communication. Defining the Core Functions helped state PHL directors to expand their vision beyond operations within the laboratory itself, and to better understand and articulate that the proper functioning of the state PHL requires a systems approach that involves many outside partners.²¹

Several reports accelerated the realization that a unified approach was needed to address the many threats to the NLS; the fundamental problem of surveillance was a continuing theme. A 1999 U.S. General Accounting Office report discussed the failure of many states to require submission of unusual or outbreak specimens to the state or appropriate local PHL, raising concerns about traditional passive surveillance to identify outbreaks.²² The same year, a report from George Washington University discussed physicians' reluctance, for various reasons, to report communicable diseases, thus, reemphasizing the need to focus upon laboratorians as the better option for acquiring surveillance data.¹⁴ Michael Skeels, Director of the Oregon State Public Health Laboratories, studied lapses in reporting by clinical laboratories in Oregon, stating that “many clinical microbiology laboratory directors now report that they can no longer perform ‘extra’pos; testing on patients for public health purposes that exceed the requirements for patient care.”¹⁶ The 1997 Lewin Group Report¹³ demonstrated that the fundamental dynamic between private and public health-care systems had deteriorated. More than half of state PHL directors reported adverse changes, including a rising burden of referred testing from managed care organizations, essentially shifting the costs of testing to the state, which was typically unable to recover costs.

Although there was clear evidence that the NLS was facing fundamental problems, these problems were largely unnoticed by the public and policy -makers. Some effective champions of the NLS concept emerged: Skeels^23,24 and Martin et al.²⁵ promoted the concept both at CDC and to clinical laboratorians, the latter being, for the most part, uninformed about the NLS and their role in it. Jon Counts, while director of the Washington State Public Health Laboratories, began the Clinical Laboratory Initiative to improve both clinical and public health testing by clinical laboratories.²⁶ As one of the first CDC-funded NLS demonstration projects, Counts addressed the problem of clinical laboratorians' lack of awareness and understanding of the Clinical and Laboratory Standards Institute (CLSI) M-100 guidelines for antimicrobial susceptibility testing (AST), demonstrating the effectiveness of disseminating the guidelines and concerted efforts to train clinical laboratorians about AST.²⁷

Several factors needed to be taken into account with regard to conceptions of the NLS: (1) there was limited understanding that the NLS already existed, and it was sometimes perceived as an entirely new system; (2) there were various interpretations and expectations of the NLS, varying from the relatively controlled system conceived by McDade and Hughes in 1998²⁸ to a more loosely controlled network; (3) there was agreement that public health reporting and rates of specimen/isolate submissions were suboptimal;²⁹ (4) while CDC had little direct influence to improve these practices, state PHLs did have the opportunity, although not necessarily the resources, to address these shortcomings because they could interact directly with clinical partners (Figure 1); (5) rather than being revolutionary, any solutions would necessarily build upon the existing infrastructure and systems, recognizing that while assuring the public's health is a nationally shared responsibility, the delivery of public health services is primarily a state responsibility; (6) clinical laboratorians tended to view their state PHLs more as competitors than colleagues; and (7) it seemed unlikely that substantial resources would be forthcoming to effect even modest changes. Although many of these themes remained, suddenly resources were less problematic as the millennium changed and as the vulnerabilities of the NLS and the need to improve it were appreciated.

ROLE OF THE LABORATORY RESPONSE NETWORK IN ADVANCING THE NLS CONCEPT

Although the previously described efforts were helpful, it was the establishment of the Laboratory Response Network (LRN)^30,31 and its rapid growth after the 2001 anthrax attacks that motivated clinical laboratorians to recognize and embrace their role in public health testing,³² especially through closer collaborations between clinical and state PHLs (Unpublished data, Bolton P, Powers A, Kroeger K. Evaluation of the process required to effectively expand the National Laboratory System [NLS] to all states. Seattle: Battelle, Centers of Public Health Research and Evaluation; September 2004). This development reinforced the need for closer cooperation between state PHLs and clinical laboratories, consistent with the NLS concept.

Even before the anthrax attacks, Congress had passed the Public Health Improvement Act, which funded initiatives in preparedness planning and coordination.³³ Supplemental emergency funding was subsequently allocated for bioterrorism and later for chemical terrorism preparedness. The LRN model includes hospital, commercial, and local PHLs as frontline partners that are most likely to be among the first to encounter cases suggestive of bioterrorism.³⁴ These laboratories perform rule-out testing on suspicious agents and, when a suspicious agent cannot be ruled out, refer them to the nearest LRN reference laboratory. These laboratories were initially called Level A LRN laboratories, denoting their primary role; they are now referred to as LRN sentinel laboratories.

To leverage this opportunity to underpin the NLS, PHL staff initiated relationships with the hospital and commercial reference laboratories that are most likely to be involved in comprehensive public health testing, including routine surveillance. Because these are the same laboratories that perform public health testing and clinical testing by virtue of their ability to perform microbial culture and identification, the establishment of lasting connections between state PHLs and LRN laboratories was a boon to public health.

Engaging stakeholders

Early on, strategic planning was understood to be necessary for defining the scope of the NLS, identifying opportunities and impediments toward strengthening the NLS, and gaining acceptance by the various stakeholders. It was recognized early that the key stakeholders included state PHL directors and their staffs, clinical laboratorians (especially microbiologists), pathologists, staff in commercial laboratories, epidemiologists, and programmatic interests at CDC. As shown in Figure 2, two early strategic planning meetings were held including representatives from these stakeholders; the first meeting was conducted at CDC and the second meeting was held at the Washington headquarters of the American Society for Clinical Pathology. These early discussions were followed with larger stakeholder meetings at CDC after the NLS Demonstration Projects had started.

Figure 2.

Timeline of National Laboratory System development,^a1999–2009

^aCollaborations to advise the NLS are shown below the X axis.

^bMcDade JE, Hughes JM. The U.S. needs a national laboratory system. U.S. Medicine 1998;34:9.

^cFunded NLS Demonstration Projects

LRN = Laboratory Response Network

NEDSS = National Electronic Disease Surveillance System

HAN = Health Alert Network

NLS = National Laboratory System

PPLIP = Public-Private Laboratory Integration Project

CLSS = Comprehensive Laboratory Services Survey

APHL = Association of Public Health Laboratories

LSS = laboratory systems and services

LOCS = laboratory outreach and communication system

L-SIP = Laboratory System Improvement Program

SPHLS = State Public Health Laboratory System

LPA = Laboratory Program Advisor

CDC = Centers for Disease Control and Prevention

NLS DEMONSTRATION PROJECTS

The NLS Demonstration Projects (NLSDPs) were designed to demonstrate the utility of better coordination, communication, and collaboration between the state PHL and clinical laboratories. One project initiated an environmental laboratory network and another project created training materials for quality assurance in laboratories that test drinking water (see descriptions of Minnesota Public-Private Laboratory Integration Projects [PPLIPs] and Wisconsin PPLIPs, respectively, in Figure 3). The Wisconsin PPLIP concluded that creation of an environmental laboratory network was likely to be even more difficult than -creation of a -network of clinical laboratories and PHLs. The Minnesota project created a training module that was used for a nationwide training program by the National Laboratory Training Network.

Figure 3.

Lessons learned from public-private laboratory integration projects in 10 U.S. states, 2004^a

^aLessons learned were described in an August 2005 conference call with the Association of Public Health Laboratories and the Centers for Disease Control and Prevention.

^bPeter Kiewit Institute. STATPack™: Version 4.0. Omaha (NE): Peter Kiewit Institute; 2008.

PHL = public health laboratory

As illustrated by these two examples, the emphasis of all the NLSDPs has been to identify and disseminate successful approaches that might be useful to other states. All the NLSDPs were advised by the CDC -Division of Laboratory Systems (DLS), and all were either directly funded by DLS or indirectly funded through a CDC-APHL cooperative agreement. This article does not describe in detail the previously published work of Counts et al.²⁷ and Michigan's NLSDP, which focused on improving antimicrobial testing practices and other public health surveillance activities in clinical laboratories.³⁵ Briefly, Counts et al. used an academic rather than state-based approach to measure gaps in the understanding and use of the CLSI M-100 guidelines for AST, and then to improve knowledge and practices after focused training. In Michigan, Boehme, Somsel, and Downes illustrated the value of the state PHL's promoting of CLSI guidelines for AST and antibiograms (CLSI M39-AS2, Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data). Their intervention increased the appropriate use of AST and antibiograms in Michigan.

The NLS pilot projects, 2000–2001

The first three state NLSDPs can truly be called pilot projects. Nebraska, Michigan, and Minnesota were selected in 2000 to determine the feasibility and barriers to integrating public and private laboratory coordination for testing of public health importance.³⁶ These projects chose different paths to address the four focal areas for NLSDPs: (1) partnership development, (2) assessment of practices and capabilities in clinical laboratories, (3) training clinical laboratorians about public health testing, and (4) promotion of standards such as CLSI standards. Applicants for NLSDP funding were instructed to select a microbial agent as a surrogate for a bioterrorism agent. A bioterrorism event was considered to be extremely unlikely to occur, so the proposed model was a relatively rare surrogate public health event, such as plague or hantavirus, which was endemic in the state applying. By using a surrogate that was rare but still likely to occur a few times during the project, states could measure baselines and demonstrate improvements after assessments, partnership building, and training or other interventions. Funds were provided to support a full-time Laboratory Program Advisor (LPA) and capital expenditures.

The 9/11 attacks and the subsequent multistate anthrax attacks highlighted the value of the NLS approach. The NLSDPs had an LPA general microbiologist with a clinical and public health background; none specialized in bioterrorism, but each was never-theless able to respond flexibly to the emergency. For Minnesota, Michigan, and Nebraska, the anthrax attacks provided a unique opportunity to illuminate the impact of the NLS model to improve (1) partnership development, (2) assessment of LRN Level A practices and capabilities in clinical laboratories, and (3) training clinical laboratorians about LRN testing protocols. Prior to the anthrax attacks, the Minnesota PHL had surveyed the capabilities of clinical microbiology laboratories to ascertain where public health testing could be diverted in an emergency. Minnesota's state PHL obtained e-mail addresses of clinical laboratories, which allowed the state to e-mail a laboratory alert on September 11, 2001, informing its clinical laboratories to be aware of the possibility of a chemical or biological attack. Throughout the anthrax attacks and the ensuing turmoil, the Minnesota state PHL successfully used its alert system for the situational awareness of its clinical laboratories, and it has since been used many times for various public health threats.

Michigan diverted its LPA to assist with statewide bioterrorism training and created a statewide network of private couriers that could assist with delivery of public health specimens, including bioterrorism specimens, to its state PHL. Prior to the bioterrorism attacks, the Nebraska state PHL created a network of laboratories, which the Nebraska LPA visited and trained regarding LRN protocols for Level A laboratories. Nebraska also created a CD-ROM with bioterrorism-related information for Level A laboratories; this CD-ROM was used as a model for a similar CD-ROM that DLS quickly produced and disseminated to Level A laboratories nationwide in November 2001 during the height of the anthrax crisis. Nebraska also created STATPack™, a telemedicine tool allowing remote laboratories to get real-time consultation from experts at the Nebraska state PHL.³⁷

When the Bioterrorism Preparedness Cooperative Agreements with the states were fully funded in 2002,³⁸ Critical Benchmark 10-B required a plan to improve working relationships and communications between Level A (clinical) laboratories and Level B/C (LRN reference) laboratories.³⁹ The lessons learned from these three states were used in regional meetings to explain to state applicants that they could hire LPAs to meet Critical Benchmark 10-B by focusing on partnership-building/recruitment of Level A laboratories, assessment of their testing capabilities and bioterrorism training needs, and training delivery.

PPLIPs, 2004

The second round of NLSDPs, entitled the PPLIPs, were funded in 2004 for capital expenditures or contracts to explore novel ways to improve communication and coordination between PHLs and clinical laboratories. The available amount of $500,000 allowed for 10 states to be funded at $50,000 each; separate bioterrorism funds were expected to be used to cover staff salaries for LPAs. The funded proposals fell into four categories: information technology, communication, environmental issues, and surveillance.

Figure 3 lists some of the lessons learned, as described by the PPLIP participants during a summative conference call. On the whole, CDC and APHL judged the PPLIPs to have been effective at demonstrating the many opportunities to benefit public health testing through better collaborations. The projects were summarized in a presentation at the 2007 Public Health Preparedness Summit.⁴⁰ The PPLIP results were summarized in the 2006 white paper “Building a National Laboratory System.”⁴¹

Initiative to integrate private laboratories into public health testing, 2007–2009

The third round of NLSDPs was funded under the cooperative agreement “Initiative to Integrate Private Laboratories into Public Health Testing” (Figure 4). Three of the funded projects concentrated on improving AST in clinical laboratories in six states, and some states included development of a statewide antibiogram.⁴² States working on AST included Wisconsin, Nebraska, and the Northern Plains Consortium (led by Montana in collaboration with North Dakota, South Dakota, and Wyoming). Other activities included: (1) development of a networking tool kit for other state PHLs to use, (2) improving electronic data transfer with network members,^42–44 (3) developing long-term consultative telemedicine capability using the STATPack™ system,³⁷ (4) improving sexually transmitted disease testing (Northern Plains Consortium) and reporting in an underserved population of Native Americans (Montana), and (5) improving use of microbiology testing services at Critical Access Hospitals (Clinical Laboratory Initiative).

Figure 4.

Initiative to integrate private laboratories into public health testing in Wisconsin, Nebraska, and Wyoming, 2007–2009

^aBroekema NM, Van TT, Monson TA, Marshall SA, Warshauer DM. Comparison of cefoxitin and oxacillin disk diffusion methods for detection of mecA-mediated resistance in Staphylococcus aureus in a large-scale study. J Clin Microbiol 2009;47:217-9.

^bKirk CJ, Shult PA. Guide to developing laboratory networks. Madison (WI): Wisconsin State Laboratory of Hygiene; May 2009. Also available from: URL: http://www.slh.wisc.edu/dotAsset/12983.pdf cited 2009 Oct 4].

^cMarshall SA, Kaufmann-Buhler T, Burda J, Klawitter J. Developing a statewide clinical laboratory network: the Wisconsin experience. Madison (WI): Wisconsin State Laboratory of Hygiene; August 2009.

^dMarshall SA, Brokopp CD, Size T. Leadership principles for developing a public health and clinical laboratory system. Public Health Rep 2010;125(Suppl 2):110-7.

^ePeter Kiewit Institute. STATPack™: Version 4.0. Omaha (NE): Peter Kiewit Institute; 2008.

AST = antimicrobial susceptibility testing

MRSA = methicillin-resistant Staphylococcus aureus

PHL = public health laboratory

IHS = Indian Health Service

STD = sexually transmitted disease

The Montana project is the first attempt to network across four states to improve communication and collaboration among several state PHLs and clinical laboratories. As was true for the previous NLSDPs, the emphasis is not merely to demonstrate the value of a new approach to integrating clinical laboratories with PHLs, but, whenever possible, to create a tool or model that can actually be extrapolated and implemented elsewhere.

PATH FORWARD: A CONVERGENCE OF SUPPORTING ACTIVITIES

A number of forces have been converging to bolster and crystallize the NLS concept. In many respects, APHL has been a driver, first through its Leadership Task Force (1998), then through the Leadership Committee (2000), and, as of 2004, through many activities under the auspices of the Laboratory Systems and Standards Committee. In 2004, Battelle finished a CDC-commissioned formative evaluation of the NLS concept. This study showed that the three NLS pilot states—Nebraska, Michigan, and Minnesota—had made substantial progress in integrating their state PHLs and clinical laboratories, and that clinical laboratories nationwide were eager for more interaction with their state PHLs, creating favorable conditions for expansion of the NLS model (Unpublished data, Bolton P, Powers A, Kroeger K. Evaluation of the process required to effectively expand the National Laboratory System [NLS] to all states. Seattle: Battelle, Centers of Public Health Research and Evaluation; September 2004).

The Battelle report recognized the importance of a more robust NLS and made several recommendations to advance it. The recommendations recognized the critical role of the LPA in the NLS and suggested that (1) a generic position description should be developed, (2) all states should hire an LPA, (3) CDC should find a way to fund LPAs, and (4) LPAs should be provided with an opportunity to meet periodically. Unfortunately, not all of these goals have been met, but the 2009 definition of the generic job description for LPAs⁴⁵ was a critical milestone. The Battelle report recommended that CDC expand funding for demonstration projects, and this expansion was accomplished through the PPLIPs and current NLSDPs (Figures 3 and 4).

These projects have also demonstrated the value of several other recommendations in the Battelle report—including recommendations that states should examine their reporting practices to clinical laboratories and that they should strive to share feedback with the clinical laboratories—indicating the important role clinical laboratories play in public health. It was recommended that existing states should mentor other states, and such mentoring is happening through various activities sponsored through APHL. It was recommended that a module that addresses public health topics should be developed for inclusion in curricula for training clinical laboratory professionals; this was addressed by the APHL National Center for Public Health Laboratory Leadership.

One recommendation was for CDC and APHL to find ways to measure the change in flow of public health information. In fact, since the SPH Laboratory System was formally defined in 2007,⁴⁶ tremendous focus has been placed on measuring all aspects of its functioning. For all of these improvements, the framing of the Core Functions²⁰ was a critical precursor, and it served as the basis for ongoing measurements of criteria that are included in Objective 23-13 of Healthy People 2010 through the biennial Comprehensive Laboratory Services Survey (CLSS).⁴⁷ Both the CLSS (beginning in 2004)⁴⁸ and the Laboratory System Improvement Program (L-SIP) (created in 2007) are measuring and thereby improving several critical elements of the SPH Laboratory System and its support of the 10 Essential Services of Public Health.^49,50

Importantly, model practices that are helpful to address improvements in the NLS are being shared among states using the L-SIP Online Resource Center (ORC).⁵¹ The L-SIP ORC is a searchable database hosted by APHL to assist states that have been through an L-SIP assessment to identify tools and other resources, including model approaches tried in other states, to help them address the system deficiencies uncovered during the L-SIP assessment.

CDC is committed to strengthening all aspects of the individual state systems and the overarching components that create a nationally integrated approach to protect the public from public health threats. In addition to DLS staff who work to promote the NLS concept, DLS is developing the NLS's Information Services, which will help public health officials identify clinical laboratories with specific testing capabilities and services.

CONCLUSIONS

Although the activities described previously are aligning to promote further development of a robust NLS, problems remain, many of which may be successfully addressed through strategic planning. On June 24, 2009, CDC and APHL cosponsored a meeting with stakeholders, representing clinical, public health, environmental, and veterinary laboratories, to initiate a strategic planning process to create a more effective NLS. Only a few of the states have been able to participate in the NLS funding (Figure 5). Policy leaders will need to determine the best way to assure that states will be able to hire and retain LPAs to work on continually improving interactions with clinical laboratories; however, no funding streams have been identified.

Figure 5.

U.S. states that have received funding for National Laboratory System Demonstration Projects

PPLIP = Public-Private Laboratory Integration Project

LPA = Laboratory Program Advisor

Cumulative experience from the various NLSDPs has shown that there are some essential elements for successful state PHLs, and the most important of these is a full-time liaison in the state PHL to interface with clinical laboratories and other partners (Figure 6). Further exploration of the best ways to brand and market the NLS concept should be explored, including how the system concept can best be leveraged by individual states. We have not yet determined the best way to share lessons learned among states, although the APHL ORC supporting L-SIP is a promising medium.⁵¹

Figure 6.

Essential elements for a successful State Public Health Laboratory System, as shown through NLS Demonstration Projects^a

^aSource: Association of Public Health Laboratories. Building a national laboratory system. March 2006 cited 2009 May 28]. Available from: URL: http://www.aphl.org/aphlprograms/lss/projects/publicprivate/nlsp2004/Documents/lab_systems_3-06.pdf

NLS = National Laboratory System

PHL = public health laboratory