Abstract
Public health laboratories (PHLs) provide specialized testing services for programs focused on the prevention and control of communicable diseases, early detection of congenital disorders, testing for antimicrobial resistance, and identification of environmental contaminants, among other responsibilities. Although national public health programs and partners provide some funding support, training, and technical resources to PHLs, no dedicated funding is provided from federal programs to fully support comprehensive PHL services across the United States or the underlying infrastructure needed for PHLs to provide and ensure their core functions and capabilities. Public health laboratories have begun to rely on a “community of practice” approach to addressing various service needs by creating and formalizing regional consortia, which are organized groups of geographically clustered PHLs that share expertise, capacities, and capabilities to enhance PHL services. The number of states participating in these networks increased from 13 to 48 from 2015 to 2020, including participation by multiple local PHLs and a territorial PHL. These consortia have enabled strengthening of partnerships and collaboration among PHLs to address regional priorities and challenges. We explore the background and evolution of regional consortia, outline some of their practices and activities, review lessons learned from these successful collaborations, and discuss the positive effect they have on the national public health system.
Keywords: laboratory, partnership, capacity building, testing, workforce development, regional consortia
Public health laboratories (PHLs) support population health through the provision or assurance of core functions and capabilities, 1,2 including communicable disease surveillance, early diagnosis of congenital disorders, and detection of environmental contaminants. These core functions and capabilities extend beyond providing laboratory test results to include technical assistance, consultation, policy development, education, and training. Successful provision of the core functions and capabilities requires PHLs to build and maintain strong partnerships in the public health system. 3 In the United States, these core functions and capabilities exist at the state and local levels in all 50 states and the District of Columbia, in addition to some US territories and other municipalities. The extent to which a PHL can directly provide certain services depends on its size, organizational structure, geography, population served, jurisdictional mandates, and funding.
Public health partners, such as the Association of Public Health Laboratories (APHL), and federal agencies, such as the Centers for Disease Control and Prevention (CDC), the US Environmental Protection Agency, the US Food and Drug Administration, and the US Department of Agriculture, provide funding, resources, training, and/or technical protocols to assist PHLs with implementation of testing and services, usually in the realm of well-defined programmatic goals. Each PHL, and its state, local, or territorial government, is nevertheless responsible for providing expertise in technical, operational, and support services and for infrastructure (eg, facilities, equipment) to ensure a wide array of testing and surveillance capability and capacity. As a result, over time, states, counties, cities, and territories have developed their own solutions in parallel to ensure access to identical or similar PHL services.
A potential model that benefits PHLs is regionalization, which is a common global strategy that creates a tiered structure and distribution of specialized laboratory test services at both the country and regional level. 4 In the United States, CDC has designed, funded, and implemented national networks to support specific programmatic goals—for example, PulseNet 5 and the Antibiotic/Antimicrobial Resistance laboratory network, 6 both of which are structured into regions.
Purpose
For PHLs to provide or assure their core functions and capabilities, they have recognized a need to complement federal, state, and local support of PHL testing and services with a regional “community of practice” approach that augments the underlying PHL infrastructure and meets the complex service needs and local priorities of PHLs. This collaborative approach has led to growing interest and participation among PHLs in regional consortia, in which members rely on their front-line perspective and practical experience to build consensus and collectively identify solutions for testing and other services. The regional consortia model is a collaborative framework for information and resource sharing, including interstate sharing of testing services when needed, without being governed by the lens of a disease or programmatic focus. States engaged in a regional consortium recognize the value of these networks in supporting PHL practice and the value brought by the consortia’s collaborative frameworks extending beyond the laboratory to other public health partners. 7 We explore the history of such regional approaches to PHL services and how these models evolved from a focus on interstate testing referral to a more holistic, bidirectional sharing of information, strategies, technical resources, and training.
Methods
The first regional consortium, the New England Public Health Laboratory Directors group, self-formed in the 1970s to address newborn screening needs 8 (Figure 1). Meetings of the consortium proved so valuable as an information exchange that in the 1980s, the group expanded the focus of activities to include leaders from environmental laboratories and became the Northeast Environmental and Public Health Laboratory Directors (NEEPHLD) consortium. 8 This consortium currently includes members from state public health and environmental government laboratories in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and the New York City PHL. 9 In 2006, the Northern Plains Consortium formed among state PHL directors and managers in Montana, North Dakota, South Dakota, and Wyoming; Idaho joined in 2013. 9 Creation of the Northern Plains Consortium followed the NEEPHLD model in response to a 3-year CDC grant to integrate PHL testing into clinical laboratories and was organized to develop a regional laboratory system and coordinate laboratory system improvement activities. These 2 consortia sustained their structure and governance for many years based on the value that PHL directors and managers placed on peer collaborations. Although these 2 regional consortia explored and implemented some test sharing and referral, the test sharing was considered secondary to the value and time dedicated to developing relationships that lead to the sharing of technical resources, training, and information across many laboratory services and technologies. 7
Figure 1.
Timeline for formation and expansion of regional consortia in the United States. Regional consortia are organized groups of geographically clustered public health laboratories (PHLs) that share expertise, capacities, and capabilities to enhance PHL services. Abbreviations: MAC, Mid-Atlantic Consortium; MRC, Midwest Regional Consortium; NEEPHLD, Northeast Environmental and Public Health Laboratory Directors; NEPHLD, New England Public Health Laboratory Directors; NPC, Northern Plains Consortium; PRC, Pacific Rim Consortium; SEC, Southeast ColLABorators.
In 2011, then–CDC Director Thomas Frieden commissioned an initiative focused on sustaining PHL services after the 2009 economic recession and the corresponding reductions in PHL funding in the United States. 10 Multiple forums asked PHL directors and staff members for input on the potential for regionalization of services. 11 A key challenge to regionalization at the time was the recognition that funding for PHL testing services varied widely among states. 12,13 States that have fewer funding resources than other states could lose core testing capabilities, which are critical for the maintenance of workforce competency, while simultaneously increasing testing turnaround times, which could negatively affect public health and clinical decisions. In addition, because state and local governments determine the needs of their communities and varying state laws and policies are in place that affect laboratory practices, numerous legal considerations and political ramifications are involved in transferring testing services out of state. 14 -16
Recognizing the challenges of regionalization, APHL and CDC provided guidance and examined existing models and solutions for service sharing within and among states. 16,17 A CDC cross-agency steering group formed in 2012 recommended resources to incentivize creation of regional consortia as a priority to promote PHL sustainability and test sharing. A funding mechanism for regional consortia was first developed through CDC’s National Public Health Improvement Initiative cooperative agreement in 2013 18 and subsequently transferred to the CDC Epidemiology and Laboratory Capacity cooperative agreement in 2014. Federal support is primarily for travel, in an effort to foster the peer-to-peer learning and collaboration that are the backbone of these consortia.
In 2015, representatives from CDC and APHL and directors from PHLs convened to address the uneven access to laboratory testing services for public health programs in states and territories, identify opportunities and barriers to supporting a shared strategy for PHL service provision in the United States, and recognize the priorities of regional consortia and strategic approaches to expanding them. 19 The momentum from this 2015 consultation led to the formation of the Southeast ColLABorators consortium (Figure 1), which included the same states that had collaborated as part of the CDC-sponsored Infertility Prevention Project. 20
Several factors bolstered formation of regional consortia over time: a general consensus on the value of the consortia to the public health system that emerged based, in part, on results of the 2015 consultation; early implementation of recommendations from interviews conducted in 2017 7 ; promotion of regional consortia through the CDC initiative; and travel support through the CDC Epidemiology and Laboratory Capacity program. Through these activities, along with outreach during the 2017 survey (which included 9 laboratory directors unaffiliated with a regional consortium), interest in forming and supporting regional consortia grew substantially. By 2017, the Mid-Atlantic Consortium formed, which included a larger local PHL presence than other regional consortia (Figure 1). 9 By 2018, states had formed regional consortia in the Midwest (Midwest Regional Consortium) and the Pacific Rim (Pacific Rim Consortium). By early 2019, the Midwest Regional Consortium expanded to include 2 additional states, and the Four Corners and Central Plains Consortium had formed and expanded its partnership beyond its original biomonitoring consortium. From 2015 to 2020, participation in regional consortia grew from 13 to 48 state PHLs, in addition to several local PHLs and a territorial PHL (Figure 2). 9 Each regional consortium had its own process for inviting potential member jurisdictions. This growing interest and participation reflect a model for strengthening PHL capabilities that emphasizes sustainability and local ownership.
Figure 2.
Members of regional consortia in the United States as of December 2020. Regional consortia are organized groups of geographically clustered public health laboratories (PHLs) that share expertise, capacities, and capabilities to enhance PHL services. Data source: Association of Public Health Laboratories. 9
Outcomes
Based on interviews with 22 regional consortia members in 2017, common benefits arose, including the sharing or referral of testing services, sharing of workforce development resources, increased capabilities in informatics and interoperability, and partnering on grant applications. 7 The interviewees identified the primary advantage to the regional consortia approach as building relationships that led to long-term and enhanced collaboration among organizations and peers, including when public health emergencies arise. The experience of Hurricane Katrina, which largely affected Louisiana and Mississippi, and the devastation in Puerto Rico during Hurricane Maria 21 illustrated the need for localities to prepare for, and respond to, public health threats. Fast-emerging public health threats such as the coronavirus disease 2019 (COVID-19) pandemic have emphasized the need for more flexible, nonhierarchical preparedness and response, which can be most effective when local jurisdictions collaborate. 22 Indeed, regional consortium members have worked together on continuity of operations plans and sharing critical COVID-19 test components among states to address national shortages of test supplies. 23
Another identified advantage was that regional consortia offer diversity in leadership and technical expertise and provide opportunities to leverage this expertise. For example, regional consortia provide forums for exchanging protocols and validation specimens and for troubleshooting when implementing new technologies. In addition, established networks were recognized as an important resource for mentoring newly hired senior staff members and providing opportunities for peer-to-peer networking. Laboratory directors who were not in a regional consortium indicated that they collaborated with other PHL directors, but their senior staff members often did not have the same opportunities to develop peer relationships. Without the formal regional network structure and collaborations, these laboratory leaders had different approaches to activities, and some were not engaged in regional test sharing, outreach to clinical laboratories, interoperability projects, or interstate trainings and technical assistance. 7
Successes of these regional consortia can be demonstrated not just by testimonials from consortium members but also through sustainability measures 24 -26 and outcomes from small innovation grants (federally funded and administered through APHL) to support training and other activities. 27 Examples include the following:
Completion of the Public Health Laboratory System Database, 10,24 which enabled the creation of a detailed directory of test services available in PHLs in the United States, including testing for severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19;
Assessment of current informatics capabilities and capacity to support cross-jurisdictional test sharing;
Completion of 8 innovation grant projects during 2017-2019 27 (in one project, the Midwest Regional Consortium conducted tabletop exercises that tested its continuity-of-operations plans and considered the collective capacity and capability of the entire network in its response);
Strengthening of leadership development through Northern Plains Consortium’s Regional Emerging Leaders Program, in which staff members from member laboratories demonstrated knowledge growth in 17 subject matter areas (eg, strategic planning, legislation, management, grant funding) 27 ; and
Knowledge gained by attendees of various continuing education events (eg, the Mid-Atlantic Consortium developed 4 training modules focused on measurement and calculations, chemistry, quality control, and other common laboratory methods to support workforce proficiency in core laboratory competencies. 28 NEEPHLD, which represents a region with a heavy influx of people, goods, and potential pathogens from across the globe, sponsored a PHL–clinical laboratory biosafety workshop in partnership with the Clinical Laboratory Management Association that offered hands-on workstations on such topics as chemical spills and donning and doffing personal protective equipment. In addition, the Northern Plains Consortium conducted a consortium-wide PulseNet workshop with its epidemiologic partners that focused on new technology, including whole-genome sequencing).
Regional consortia have been supported by multiple resources, including funding from CDC for travel for in-person meetings in recognition that face-to-face time is critical for relationship building and development of governance, strategic priorities, and project action plans. Other resources and tools, provided or coordinated by APHL, have included the following:
A liaison to coordinate meetings and conference calls;
Tools, templates, and facilitator support for in-person meetings;
A central document repository 19 and an APHL regional network web page 9 ;
Data and guidance to inform members, such as reports from a 2018 Training Needs Assessment 29,30 and information on current informatics capabilities to support cross-jurisdictional test sharing 31 ;
Regular, joint regional conference calls with all network participants invited; and
A Regional Consortia Coordination Council with representatives from each consortium serving as a liaison for communication and information sharing among the regional consortia. Council representatives will provide guidance to convene another consultation in 2021.
Lessons Learned
The PHL system must continuously provide comprehensive testing services that meet the needs of the populations being served and the needs of the larger, national public health system. Local solutions can often be developed and applied to other jurisdictions that have similar public health concerns, vulnerabilities, and resource limitations. 10,19 Consequently, some PHLs established relationships within and across state boundaries—a concept that is supported at the national level for cross-jurisdictional sharing among public health departments. 32 Public health laboratories have long relied on each other for as-needed assistance or collaborations, including the experience of 7 states that formed an ad hoc consortia in 2020 to purchase COVID-19 test supplies. 33 PHLs have also depended on each other for regular, ongoing service sharing, such as providing newborn screening tests for other jurisdictions. 16,17,34 Public health laboratories have now matured along the spectrum of cross-jurisdictional sharing arrangements 32 to formal, defined communities of practice in the form of regional networks. Although early adopters of the regional consortia model benefited from these arrangements, active promotion of the regional consortia concept by CDC and outreach by APHL were needed to increase participation. Starting in 2017, momentum in forming regional consortia rose steeply as numerous PHLs demonstrated considerable interest; currently, nearly all US states actively participate in a consortium.
Although the value of PHLs working collaboratively to exchange information, share best practices, develop shared resources, and enhance workforce development has been realized, some challenges remain. Given that the membership and organization of regional consortia are voluntary, jurisdictions need the active support and assistance of their respective agencies. Projects that require formal memoranda of understanding/memoranda of agreement have been difficult to establish, particularly because of legal differences among states. Test sharing across jurisdictions can be problematic when invoicing or exchanging funds is required. 15 In addition, implementation of informatics and interoperability projects is expensive and can be difficult to justify to state health officials in the absence of a funding source. 7 These challenges, coupled with tight budgets, understaffing, and out-of-state travel restrictions on some laboratories, have resulted in barriers to expanding participation at in-person meetings or trainings. However, the level of engagement in regional consortia has generally been high, with 86%-93% participation at in-person meetings from 2017 to 2019. 26 Lastly, APHL’s programmatic support, tools and resources, and coordination of the innovation grants have been major contributing factors to maintaining regional consortia, successfully completing and implementing projects, and sharing information across the consortia. Future work is planned to continue evaluating the processes, outcomes, and effect of regional consortia.
Regional consortia strengthen the public health system through sustainability and resilience across multiple PHL testing programs and services and by empowering local decision making through collaborative relationships. These regional consortia offer a unique model to maintain timely response to population service needs without sacrificing capacity or capabilities. Opportunity exists for the PHL community and partners to expand the dialogue on the role and effect of regional consortia, including during the ongoing COVID-19 pandemic, and how these multistate collaborations can serve as a strategy to complement programmatic-specific approaches by strengthening all facets of PHL practice and to create a comprehensive community of practice for sharing resources and services.
Acknowledgments
The authors thank Rex Astles of the Centers for Disease Control and Prevention, Center for Surveillance, Epidemiology, and Laboratory Services, Division of Laboratory Systems, for his early contributions to the article.
Footnotes
Declaration of Conflicting Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This article was supported by cooperative agreement no. NU60OE000103 by the Centers for Disease Control and Prevention (CDC). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC or the US Department of Health and Human Services.
ORCID iD: Bertina Su, MPH
https://orcid.org/0000-0002-7304-7833
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