Leadership Principles for Developing a Statewide Public Health and Clinical Laboratory System

SYNOPSIS

In 1999, the Centers for Disease Control and Prevention (CDC), the Association of Public Health Laboratories (APHL), and the Federal Bureau of Investigation established the national Laboratory Response Network (LRN) for bioterrorism readiness. A more broad application of the LRN is the National Laboratory System (NLS), an effort to promote the 10 Essential Public Health Services and the Core Functions and Capabilities of State Public Health Laboratories (hereafter, Core Functions). State public health laboratories (PHLs) are responsible for leading the development of both the LRN and the NLS in their jurisdictions. Based on the experience of creating a laboratory network in Wisconsin, leadership principles are provided for developing and strengthening statewide laboratory networks of PHLs and clinical laboratories, which can also include point-of-care testing sites. Each state PHL, in the context of these Core Functions and leadership principles, sets its priorities, budgets, and strategic plans. For a limited investment of personnel and funds that will yield a large benefit to public health, a robust state laboratory system can be established.

In 1999, the Centers for Disease Control and Prevention (CDC), in partnership with the Association of Public Health Laboratories (APHL) and the Federal Bureau of Investigation, established the framework for a national Laboratory Response Network (LRN), whose objective would be to ensure an effective laboratory response to bioterrorism by helping to improve the nation's public health laboratory (PHL) infrastructure.¹

The LRN framework for biological terrorism is currently visualized as a pyramid with three organizational tiers (Figure 1). At the apex of the pyramid are several federal governmental laboratories, such as those found at CDC and within the U.S. military system. These national laboratories employ scientists who are specially trained to work with highly infectious agents in high-containment facilities. The second tier consists of more than 150 state PHLs and other governmental laboratories with advanced skills that qualify them to be reference laboratories. These reference laboratories are capable of agent isolation and diagnostic testing, as well as rapid detection using sophisticated molecular testing protocols. The third tier, which is at the foundation of the pyramid, consists of more than 25,000 private and commercial laboratories nationwide that serve as sentinels to the system. The majority of the sentinel laboratories are independent and hospital laboratories that participate in the day-to-day health of their local communities, putting them in an ideal position to act as the early warning system for emerging health issues.²

Figure 1.

Hierarchical organization of the Laboratory Response Network (LRN)

As state laboratories proceeded to implement this new CDC directive, it became apparent in Wisconsin that not only was it necessary to enhance and expand existing relationships with clinical laboratories, but relationships also needed to be developed with those entities that relied on laboratory services, data, and expertise. Without this full array of partners, it would not be possible to identify man-made or naturally occurring health threats and initiate effective and timely responses.³

With increased use of rapid point-of-care waived diagnostic kits in physicians' offices, non-laboratory staff now perform the work of laboratory technologists. There is a need to extend laboratory networks to include the more than 200,000 physician offices in the United States, as these testing sites are rapidly becoming a main source of surveillance data and microbial isolates for state PHLs. In Wisconsin, these physician offices also rely on training and surveillance data provided by the Wisconsin State Laboratory of Hygiene (WSLH) to help guide their diagnostic and treatment decisions.

THE NATIONAL LABORATORY SYSTEM

A more broad application of the LRN is the National Laboratory System (NLS). In a collaborative effort to promote the 10 Essential Public Health Services⁴ and the Core Functions and Capabilities of State Public Health Laboratories,⁵ in 2000 CDC and APHL developed the concept of the NLS. The vision of the NLS is to link private-sector, clinical laboratories in the U.S. with public health, veterinary, food safety, and environmental testing laboratories to create seamless systems within each state to enhance public health surveillance, emergency response, laboratory support, and quality improvement^6–10 (Figure 2). Key objectives of the NLS include assessing and monitoring laboratory capacities, increasing coordination and communication among laboratories, building partnerships between public and private laboratories, developing the laboratory workforce through training and education, and promoting laboratory standards.¹¹

Figure 2.

State Public Health Laboratory System partners as depicted in the APHL State Public Health Laboratory System: Performance Standards User's Guide^a

^aAssociation of Public Health Laboratories, Laboratory Systems and Standards Subcommittee. State public health laboratory systems: performance standards user's guide. Silver Spring (MD): APHL; June 2007. Also available from: URL: http://www.aphl.org/aphlprograms/lss/projects/performance/Documents/users_guide.pdf [cited 2009 Oct 4].

APHL = Association of Public Health Laboratories

EMS = emergency medical services

CHC = community health center

The success of the NLS depends on the creation of fully integrated and coordinated laboratory networks in every state, managed and coordinated by the state PHL. Using special collaboration projects, CDC and APHL are attempting to improve system capabilities to collect and share surveillance data and to standardize practices for state networks. By providing training and outreach, and through improved surveillance networks, a two-way exchange occurs that incorporates best practices and public health-related research opportunities. Network interaction results in quality improvement at all system levels (Figure 3). However, coordinating a collaborative network of laboratory partners is not an easy task. Although every state has different needs, resources, and organizational structures, the principles of collaboration remain the same.

Figure 3.

The expansion of the LRN concept to an NLS concept, including point-of-care testing in physician offices

LRN = Laboratory Response Network

NLS = National Laboratory System

CDC = Centers for Disease Control and Prevention

THE WISCONSIN CLINICAL LABORATORIES INTEGRATION PROJECT

Each state PHL operates within the parameters of its mission and the boundaries of its jurisdiction. Most PHLs are not distinct entities, but exist within the organizational hierarchy of the state's public health department. The role, structure, and even funding of the PHLs vary widely.

In 2006, the WSLH was awarded a three-year NLS cooperative agreement from CDC as part of a federal initiative to integrate clinical laboratories into public health testing. Wisconsin is one of several states that have successfully developed a robust clinical laboratory network that addresses both emergency preparedness and routine microbiology issues. In the last two decades, the WSLH has provided training resources, regional meetings, and teleconferences that benefit both local public health departments and private laboratories statewide. The laboratory surveillance conducted by the WSLH, a collaborative effort with the Wisconsin Division of Public Health, has also resulted in quality public health data that impact state and local public health policy decisions.

The first grant deliverable was the Guide to Developing Laboratory Networks, from which other state PHLs may benefit from some examples of Wisconsin's successes and failures. This guide defines the steps used by WSLH to build a statewide laboratory network of public health and private-sector microbiology laboratories.¹² While developing this guide, two primary factors became apparent to the success of networks. The first was the support of the state PHL's administrators and the many clinical laboratory decision makers. Results from a recent survey of all Wisconsin Clinical Laboratory Network (WCLN) administrators revealed that while many were not directly involved in the network's operations, nearly all recommended similar networks to colleagues in other states (data on file at WSLH). The key to this finding is that hospital administrators do understand the benefits of such a network enough to support (or at least to not prohibit) their laboratory's involvement.

The second factor was the support and involvement of the laboratory network participants. Time and again, WSLH staff were amazed at the time and effort that private clinical laboratory directors and managers put into the network. From presenting at statewide workshops and teleconferences to defining and steering the network itself as part of the network advisory committee, these participants clearly saw the network's mutual benefits at all levels. The network members benefit from increased education, communication, and collaboration among colleagues, and improved laboratory surveillance that, overall, can result in faster identification of outbreaks and better patient outcomes.

In focus group meetings of WCLN participants, the network staff asked for member stories about their experiences with the network, both good and bad. Members were asked about the perceived effects of the network on both staff and patients, their understanding of the purpose and operation of the network, and what potential future roles were possible for the network in terms of advocacy, data sharing, new testing techniques, workforce development, and cost efficiencies. This focus group resulted in an introductory video segment that briefly summarizes the WCLN experience. The video was provided as a second deliverable distributed to all state PHL directors via APHL, with the networking guide and materials as a networking “tool kit.”¹³ This article represents a third deliverable—a publication on collaborative principles needed to develop and sustain a successful laboratory network.

COLLABORATION REQUIRES DELIBERATE ACTION

Often when networks are developed, they are done so without considering the theoretical underpinnings of collaboration. Most just forge ahead without understanding the theory behind network and partnership building, as was the case in Wisconsin. Upon reflection, a study of this theory has offered us an opportunity to reevaluate and strengthen our existing partnerships.

There are two basic organizational models in society: a dominator model, which emphasizes authoritarian (vertical) relationships, and a partnership model emphasizing collaboration (horizontal).¹⁴ While both approaches have existed for a very long time, the application of network models in the health sector is now receiving serious and, some would say, overdue attention. As a 2000 Institute of Medicine report stated, “Government public health agencies, as the backbone of the public health system, are clearly in need of support and resources, but they cannot work alone. They must build and maintain partnerships with other organizations and sectors of society, working closely with communities and community-based organizations, the health care delivery system, academia, business, and the media.”¹⁵

Collaboration is by no means a new idea, but public health professionals are significantly more familiar, and maybe even more comfortable, working within single institutions rather than in competitive environments or markets. To build partnerships, it is helpful to understand them as cross-cultural exercises—requiring competence to navigate the differences among multiple organizations and sectors with significantly different missions, management structures, and sources of funding.

The successful development and maintenance of a laboratory network fundamentally depends on strong network leadership. Developing and supporting a statewide laboratory network with voluntary participants involves a different set of skills than those used in managing an agency or institute. Even within a single state such as Wisconsin, system concepts are viewed from many different perspectives. A major difference is one observed repeatedly: government public health agencies will use the phrase “public health system” broadly, to include many entities outside of the public sector (Figure 2). At the same time, private entities rarely think of themselves as part of the public health system. This perception is not a trivial barrier to developing a common mission for a network.

While state laboratories have been reaching out to establish or strengthen statewide networks, clinical laboratories have been receptive to collaboration. Recognition of the roles played by federal and state agencies and public and private laboratories in meeting the challenges of such emergencies as Hurricane Katrina and Escherichia coli contamination of spinach helps to foster such collaboration. De Pree, in Leadership Is an Art, offers an approach based on his experience that aggregate corporate productivity is increased to a maximum by working in collaboration with individual work sites and employees.¹⁶ De Pree's eight leadership principles are outlined in this article as a suggested platform in the context of developing and strengthening statewide laboratory networks (Figure 4). Operational transparency, mutual involvement, mutual benefit, and a clear understanding of the network's vision and mission are essential. As these principles are put into practice, a number of questions (Figure 5) must also be addressed.^17–19 For example: Are the network operational rules clearly defined? And how formal or informal will the operational rules be?

Figure 4.

Eight leadership principles^a as a guide for developing collaborative laboratory networks

^aSource: De Pree M. Leadership is an art. East Lansing (MI): Michigan State University Press; 1987.

^bScott S. Fierce conversations: achieving success at work and in life, one conversation at a time. New York: Penguin Putnam Inc.; 2002.

Figure 5.

Questions to consider as a statewide laboratory network is being constructed

CONCLUSIONS

The benefits of the NLS include improved surveillance activities, more rapid and focused responses to public health emergencies, and a more informed and connected health-care community. Many of the barriers to fully implementing such a system remain within the state PHLs. The responsibility to lead the development and management of a robust statewide laboratory network is implied, if not implicit, within the Core Functions.⁵ Among the Core Functions that directly relate to the benefits offered by networks with clinical laboratories are emergency response; partnerships and communication; reference and specialized testing; disease prevention, control, and surveillance; training and education; and laboratory improvement and regulation. Most of the remaining Core Functions can also be indirectly impacted from the activities of laboratory networks, such as public health-related research, integrated data management, food safety, and policy development.

Each state PHL, in the context of these Core Functions, must set its priorities and strategic plans. For a limited investment of personnel and funds that will yield a large benefit to clinical laboratories and PHLs, and the overall public health system, a state laboratory network can be established.