Competency Guidelines for Public Health Laboratory Professionals: CDC and the Association of Public Health Laboratories

Prepared by

Renée Ned-Sykes, PhD1

Catherine Johnson, MA2

John C. Ridderhof, DrPH1

Eva Perlman, MPH2

Anne Pollock3

John M. DeBoy, DrPH2

1Office of Public Health Scientific Services, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia

2Association of Public Health Laboratories, Silver Spring, Maryland

3Office of Public Health Scientific Services, Center for Surveillance, Epidemiology, and Laboratory Services, Division of Laboratory Systems, CDC, Atlanta, Georgia

Corresponding preparer: Renée Ned-Sykes, RNed@cdc.gov, 404-498-0125.

Summary

These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory (PHL) professionals to deliver the core services of PHLs efficiently and effectively. As part of a 2-year workforce project sponsored in 2012 by CDC and the Association of Public Health Laboratories (APHL), competencies for 15 domain areas were developed by experts representing state and local PHLs, clinical laboratories, academic institutions, laboratory professional organizations, CDC, and APHL. The competencies were developed and reviewed by approximately 170 subject matter experts with diverse backgrounds and experiences in laboratory science and public health. The guidelines comprise general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent, proficient, and expert. The 15 domain areas are 1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research.

These competency guidelines are targeted to scientists working in PHLs, defined as governmental public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies. The competencies support certain PHL workforce needs such as identifying job responsibilities, assessing individual performance, and providing a guiding framework for producing education and training programs. Although these competencies were developed specifically for the PHL community, this does not preclude their broader application to other professionals in a variety of different work settings.

Introduction

The national network of governmental public health, environmental, and agricultural laboratories, referred to collectively as public health laboratories (PHLs), is a vital part of the U.S. public health infrastructure. These laboratories perform multiple functions through provision of analytic biological and/or chemical testing and testing-related services that protect human populations from infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and other natural and human-made public health emergencies (1–3). A well-trained laboratory workforce is essential to ensuring that PHLs have the capacity to carry out the critical activities that are needed to safeguard the public's health competently and effectively (4,5).

Studies of the PHL workforce have drawn attention to several concerns about staff training and projected turnover, both of which highlight challenges to maintaining a sufficient number of highly skilled and competent workers. A 2011 national PHL workforce characterization survey found that approximately one third of PHL directors nationally expected 16%–25% of their workforce to retire, resign, or be released in the subsequent 5 years, while 12% anticipated losing 26%–50% of their workforce during that time period (6,7). Approximately 30% of the individual scientific staff respondents expected to continue working in a PHL for <5 years (6). These findings largely reflect workforce demographics, because more than half of scientific laboratory staff were aged >45 years (6). Important recruitment and retention challenges for the PHL workforce also have been identified, including the lack of established progressive job series (commonly termed "career ladders" in the PHL community) for PHL scientists (6–8) and the lack of adequate opportunities for training and professional development (6,7). Indeed, approximately 50% of laboratories reported no, minimal, or only partial capacity to provide continuing education and training to their workers (6,7). Lack of adequate training poses challenges because PHL scientists and managers require a range of scientific, leadership, and managerial development courses, ideally based on core competencies, to function effectively in their positions (9–11).

Multiple national professional organizations, including the Institute of Medicine, the Association of Schools and Programs of Public Health, and the Public Health Foundation/Council on Linkages Between Academia and Public Health Practice (Council on Linkages), among others, have endorsed competency development as a means of strengthening the public health workforce (12–15). Competencies improve the workforce by providing a guiding framework for producing education and training programs, identifying worker roles and job responsibilities, and assessing individual performance and organizational capacity (12–18).

Competencies are action-oriented statements that delineate the essential knowledge, skills, and abilities that are critical to the effective and efficient performance of work (19); competencies should be observable and measurable. Several public health professional disciplines have developed competencies, often through federal partnerships, to address workforce education and training needs (14,15,19–24), and competency-based curriculum development has been suggested as the ideal method for training public health workers and public health students (10,11,13,18,25). In 2009, CDC and APHL collaborated to develop guidelines for biosafety laboratory competency (26), followed by development of this broader set of guidelines for PHL professional competency.

Purpose

The purpose of these guidelines is to outline the knowledge, skills, and abilities that public health laboratory professionals (principally scientists, managers, and leaders) need to deliver the core services of PHLs efficiently and effectively. These guidelines establish core competencies that can help direct workforce development efforts in PHLs in the United States. Because the competencies are universal in nature for many laboratory disciplines, the guidelines also have potential value for laboratories (including those not characterized as public health laboratories) located in both developed and developing nations.

Background

CDC and APHL have engaged collectively in multiple laboratory workforce improvement efforts over the past several years, providing the foundation for the development of these guidelines. More information about these efforts is available at http://www.aphl.org. The 2011 launch of the Laboratory Efficiencies Initiative (27) was intended to assist PHLs in achieving long-term sustainability and resulted in recommendations from multiple forums to focus greater efforts on PHL workforce development. As part of these efforts, APHL collaborated with CDC in 2012 to develop a comprehensive set of competencies that built on APHL's earlier work to draft competencies for PHL professionals across several topic areas (APHL, unpublished draft, 2011). The scope of that project then was expanded to include a broader range and depth of technical and nontechnical competencies, resulting in the guidelines presented in this report. These guidelines for PHL professionals were developed through the engagement of subject matter experts from APHL, CDC, state and local PHLs, federal environmental and agricultural laboratories, clinical laboratories, and academia to ensure appropriate input and vetting.

Methodology

The PHL competencies were developed over a 2-year period through a consensus process involving 108 subject matter experts participating through a variety of committees, workgroups, and teams (Box). In August 2012, CDC and APHL established an 11-member CDC/APHL Steering Committee* to provide direction, guidance, and oversight to the overall competency development process. A 38-member Project Planning Workgroup comprising CDC, APHL, and PHL representatives encompassing a range of expertise (e.g., PHL leadership, informatics, microbiology, and environmental chemistry) was created through consultation with a nationally recognized expert in competency development and was charged with establishing the competency development process. A 2-day meeting of the Project Planning Workgroup (which included the members of the CDC/APHL Steering Committee) facilitated by AlignOrg Solutions was held in Atlanta, Georgia, in October 2012 to define the project scope and target audience, prioritize expectations of stakeholders, discuss methods and criteria for writing competencies, determine the structure of the competencies, and develop a list of draft competency domains to represent the main subject areas in which PHL professionals operate.

Eleven Domain Teams then were established to develop competencies for 14 draft competency domains; an additional domain focused on ethics was developed later in the process. Most team leads and many members were drawn from the Project Planning Workgroup. Each team lead was responsible for making recommendations regarding team membership to the CDC/APHL Steering Committee and APHL staff, who vetted potential members. Domain Team leads were encouraged to recruit a diverse group based on employer type (government and nongovernment, and federal, state, and local), geographic locale of employment, and years and range of experience (laboratory scientists, managers, and leaders). A total of 90 subject matter experts from CDC, state and local PHLs, APHL, academic laboratories, clinical laboratories, the U.S. Department of Agriculture, and others served on the various Domain Teams.

A Development Workgroup created template documents to assist the Domain Teams in constructing their respective competency sets and to ensure uniformity to the process. This Workgroup, which comprised staff from CDC, APHL, PHL, and AlignOrg Solutions, conducted literature reviews and Internet searches to identify related materials, including laboratory association guidelines and reports as well as competency sets for nonlaboratory audiences that had application for PHL functions or specific domain areas (e.g., management, leadership, and workforce training). Although applicable literature was located for eight domain areas (Quality Management System, Management and Leadership, Ethics, Safety, Research, Emergency Management and Response, Workforce Training, and Informatics), limited material was found related to the remaining competency domains. Formal systematic review methods were not used because of the scarcity of available literature, especially regarding laboratory-specific content. In December 2012, the Development Workgroup met to draft a template document for each competency domain, consisting of main competency statements comprising one or more subcompetencies that were further defined by draft responsibility statements at one or more proficiency levels. The Workgroup members used the available literature when applicable but relied principally on their subject matter knowledge and personal work experience as a basis for drafting the template documents.

During January 2013–April 2013, each Domain Team held regular, facilitated conference calls to develop and refine their respective domain competencies, using the template document provided by the Development Workgroup as a starting point. Each team relied on member expertise to arrive at consensus on all competencies, subcompetencies, and proficiency tier statements. The 14 proposed PHL competency domains were mapped against the core functions of PHLs (2,3), the Council on Linkages Core Competencies for Public Health Professionals (14), and the CDC/Council of State and Territorial Epidemiologists Applied Epidemiology Competencies (15) to assess congruence with these materials and to identify gaps in the draft PHL competency domains.

In April 2013, a six-person Synthesis Workgroup was established to review and assess the draft domain documents for gaps and overlaps in content and to harmonize language across domains. During May–November 2013, the Workgroup's efforts focused on developing definitions for each domain, continuing to harmonize content and address gaps and overlaps, developing an online survey tool for the competency validation process, and soliciting reviewers to evaluate one or more competency domains.

Validation Process

The CDC/APHL Steering Committee identified the organizations and agencies it wanted to target for involvement in the competency validation process. Following a solicitation for reviewers, APHL staff contacted 139 potential reviewers on the basis of their knowledge and background in one or more particular domain areas. Of these, 75 were invited and agreed to participate in the review phase. Reviewers were drawn from state and local PHLs, CDC, APHL, clinical laboratory organizations, and food-testing laboratories, as well as former PHL directors and other expert consultants. Fifteen reviewers already had been involved in the competency development process in some capacity and offered to review domains that they did not take part in developing. Reviewers were given 45 days during November 2013–January 2014 to assess the validity of the content for the particular domain(s) reviewed and to provide comments and recommendations for improvement through an online survey tool. The reviewers based their responses on their knowledge and experiences in laboratory practice. In December 2013, an Adjudication Process Workgroup of APHL, CDC, and PHL representatives met to design and establish the process for adjudicating reviewer comments, including a method for each Domain Team to document its response to each comment received. At the end of the vetting period, all reviewer comments were collated and reviewed by APHL staff, and a consolidated listing of comments was forwarded for review to the Domain Teams.

The extensive nature of the comments for the General Laboratory Practice and Emergency Management and Response domains prompted the CDC/APHL Steering Committee to create dedicated teams for each of these domains. Several competencies and subcompetencies for the General Laboratory Practice domain had been extracted previously from the Chemistry and Microbiology domains, with additional content developed by a small work team. The new General Laboratory Practice Domain Team included representatives from the Chemistry, Microbiology, Quality Management System, Research, and Communication Domain Teams. Content for the Emergency Management and Response domain had also been developed initially by the Chemistry and Microbiology Domain Teams. In light of the vetting period comments, the Emergency Management and Response domain competencies were rewritten by a dedicated team that included members from APHL's Public Health Preparedness and Response department and the APHL Public Health Preparedness and Response Committee. Similarly, content for the Ethics domain had been extracted from a number of existing domains, and three Domain Team volunteers formed a new team to examine comments received. All Domain Teams held as many conference calls as needed during January–March 2014 to consider and address the vetting period comments.

In April 2014, a Harmonization of Domains Workgroup met to review major changes that the Domain Teams had made to the draft competencies in response to reviewer comments and to address any remaining overlaps in content and inconsistencies in approach and language among the competency domains. The Workgroup also resolved outstanding issues related to vetting period comments that the Domain Teams were unable to address individually in a consensus process. This workgroup comprised nine Domain Team leads, two CDC/APHL Steering Committee members, the APHL project manager, and an invited representative of CDC. Workgroup members then split into small teams and met via teleconference during April–July 2014 to finalize the competency domains.

In total, the competencies were developed and reviewed by approximately 170 professionals with diverse backgrounds and experiences in laboratory science and public health. The final draft of the competency guidelines was reviewed by the CDC/APHL Steering Committee in October 2014. The final competency guidelines were reviewed and approved by CDC in February 2015.

Guiding Principles

Scope

The competency guidelines were developed specifically for scientists working in PHLs. APHL defines PHLs as governmental public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies (http://www.aphl.org/aboutaphl/aboutphls/pages/default.aspx). Although intended primarily for the continuum of scientist positions from laboratory assistant to laboratory director, these competencies can be used by other PHL staff as well. In fact, all staff (including administrative and support staff, custodial staff, and information technology specialists) can apply competencies within the Security, Safety, Emergency Management and Response, and Ethics domains. Any staff members with responsibilities for data entry, records management, client services, supply services, and other nonbench functions would benefit from application of competencies across additional domains depending on their job function and responsibilities.

Although these competencies were developed expressly for the PHL community, this does not preclude their broader application to a variety of other work settings, because many of the skill sets are similar. Scientists, trainers/educators, and leaders and managers in clinical laboratories, veterinary laboratories, academic and private research laboratories, and other laboratories may use these competencies as a basis for further development of their workforce and local/institutional staff. Laboratories using these competencies should be mindful of federal, state, local, and institutional regulations and standards addressing topics such as safety and security when adopting competencies in practice.

Competencies and Skill Domains

These guidelines were developed on the basis of the Dreyfus Model of Skill Acquisition, which states that five progressive stages of development are associated with skill proficiency (18,28). Learners are able to handle additional responsibility and adjust to different and more complex situations as they gain proficiency. For these competency guidelines, the Dreyfus Model was modified in that four proficiency tiers are used: beginner, competent, proficient, and expert. Descriptions of the proficiency tiers are provided (Appendix A).

Competencies were written by using Bloom's taxonomy as a framework; action verbs describing activities that are observable and measurable were used to signify or relate to a hierarchy of learning and actions (29,30). The hierarchy of responsibilities is based on the science for competency development that has been applied across numerous disciplines. Competencies typically are structured as broad statements that define what is expected of and can be demonstrated by the learner; therefore, specific tasks or methods to achieve the competency at a particular proficiency level are not delineated. Each user is responsible for deciding the needed activities, which might vary substantially because of the diversity that exists within and across public health laboratories. Consequently, competency statements do not refer to or include the frequency with which a responsibility is exercised. Nor, with rare exceptions, do they refer to specific guidelines, standards, or regulations, because these might differ by discipline and type of laboratory. The competencies focus on the knowledge, skills, and abilities required to perform a range of activities in the PHL. The competencies convey the capability for a given behavior or skill, even if the opportunity to perform that skill or behavior is not available (e.g., to serve on national committees or instruct others in policies and processes).

A total of 122 competencies and 519 subcompetencies were identified for the PHL workforce across 15 competency domains: 1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research (Figure). Full descriptions of these domains and listing of their competencies, subcompetencies, and responsibility statements are presented (Tables 1–15). A number and lettering schema is used to identify domains, competencies, and subcompetencies. Domains are identified by three-letter initials (e.g., QMS), competencies are identified by the domain initials and an overall number (e.g., QMS 1.00), and subcompetencies are further identified through expansion on the competency numbering system (e.g., QMS 1.01 and QMS 1.02).

Three types of domains are included in this competency set: 1) general domains that apply to the responsibilities of all PHL professionals (i.e., Quality Management System, Ethics, Management and Leadership, Communication, Security, Emergency Management and Response, and Workforce Training); 2) cross-cutting technical domains that apply to all laboratory scientists regardless of the scientific discipline in which they work (i.e., General Laboratory Practice, Safety, Surveillance, and Informatics); and 3) specialized domains that are specific to laboratory scientists working in particular scientific disciplines or specialized functional areas (i.e., Chemistry, Microbiology, Bioinformatics, and Research) (Figure). The General Laboratory Practice domain is broadly applicable because it includes general topics pertinent to the laboratory workflow across a wide array of testing areas. Many of these subcompetencies are not duplicated in the specialized domains. Consequently, the General Laboratory Practice domain serves two purposes: to be a companion to each specialized domain and to function as a quasispecialized domain for testing activities not encompassed by the Microbiology or Chemistry domains. Because many topics are relevant to more than one competency domain, the Harmonization of Domains Workgroup decided when to have intentional overlap of particular subcompetencies or topics across domains. For example, the General Laboratory Practice, Research, and Management and Leadership domains include ethics-related competencies although there is a separate Ethics domain.

For all domains, the competencies and proficiency tier statements are context-driven. A given verb is not limited to occurring at only one specific level of proficiency, as the complexity of the described action is determined by the context. In addition, some subcompetencies are similar across domains, in which case users should be mindful of the specific context. For example, sample collection, labeling, and handling are primary functions for both chemistry and microbiology. The subcompetency language for this group of activities is similar in the Chemistry and Microbiology domains, although the specific actions (tasks) needed to achieve each level of proficiency might be different between the testing disciplines.

Each subcompetency outlines a cumulative acquisition of skills, with each successive proficiency tier assuming that a person has acquired the knowledge, skills, or abilities stated in the lower proficiency tier for a given subcompetency. However, the amount of time required for a worker to achieve competency at a particular proficiency tier might be highly variable. In particular, the beginner phase could encompass a very short time frame for some subcompetencies while requiring a longer time for others, depending on the specific action described. Regardless, all beginner tier statements assume that work will be performed under supervision. Furthermore, all statements of the four proficiency tiers are written under the assumption that work will be performed according to standard operating procedures, processes, and policies approved by the administration of the laboratory and in adherence to applicable regulations and accreditation standards and guidelines.

Finally, no recommendation is made that any particular job title or academic degree is required for a particular proficiency tier, nor is the complexity of the knowledge, skills, and abilities for a given proficiency tier the same for all competencies. For example, a PHL scientist could be at the beginner tier for some subcompetencies while being at the competent or proficient tier for others. Similarly, a person might acquire some expert tier competencies early in their career despite not having supervisory or management responsibilities. Many expert competency statements, however, apply to a person occupying a position commensurate with a laboratory director, as significant experience and expertise are required.

Intended Use

These guidelines provide highly structured competencies intended to help ensure a capable, well-trained, and prepared laboratory workforce. The competence of the PHL workforce has a direct impact on the quality of the work output and products required to protect the public's health. Each competency and subcompetency within every domain might not apply to all laboratory staff. The competencies should be tailored and applied to the greatest extent possible to the individual user's situation. Personnel can use the competencies to assess their current skill level and define other areas in need of additional training, with a goal of achieving higher proficiency over time. Laboratory directors and human resources staff might find the guidelines helpful in creating standardized job descriptions, defining progressive job series, recruiting new staff, assessing organizational capacity, and developing performance objectives and appraisals that are aligned with the competencies. Laboratory managers may employ the guidelines as a reference for performance management strategies. The competencies provide a framework for assessing performance and could be used to prepare for certification examinations and for meeting staff qualification requirements specified by governmental laboratory personnel regulations. Finally, educators and training developers may use the guidelines to develop and refine PHL workforce development plans to assess and address training needs through the design of education and training programs.

It is important for users to review the definitions associated with these guidelines (Appendix B). As terms might have different meanings in the context of different laboratory types, the terminology for this project has been standardized to provide more clarity and ease in applying the competencies to practice settings. In situations in which glossary terms contain more than one possible definition, the particular definition applicable to a domain is footnoted for that domain.

Dissemination

CDC and APHL plan to disseminate these guidelines broadly to a variety of stakeholders, including, but not limited to public health laboratories, clinical laboratories, academia, and laboratory scientist professional organizations such as the American Society for Clinical Pathology, the American Society for Clinical Laboratory Science, the Association of Food and Drug Officials, the Association of American Feed Control Officials, the Clinical Laboratory Management Association, and the Clinical and Laboratory Standards Institute, some of which participated in the competency validation process. The competencies will be presented at meetings of public health practitioners and laboratory professionals. The guidelines also will be displayed on APHL's website (http://www.aphl.org).

The next stage of this PHL competency project will focus on the development of tools and resources to aid in guideline implementation. These might include sample competency-based job descriptions and examples of ways professionals can demonstrate competency in a specific area; highlight case study examples of competencies in use; and provide models for developing training and fellowship programs tied to performance metrics and competencies. For example, the Emerging Infectious Diseases Fellowship Program, which is sponsored by APHL and CDC, could use guidance in the toolkit to integrate these competencies into a training program similar to the manner in which the CDC-sponsored Epidemic Intelligence Service program (31) integrated the Applied Epidemiology Competencies (15). Tools and resources to support implementation will also be displayed on APHL's website (http://www.aphl.org) as they are developed.

CDC and APHL also aim to develop a sustainability plan to evaluate the adoption, use, and need for revision of these guidelines periodically. The Council on Linkages (14) and the Clinical and Laboratory Standards Institute (32) provide models for competency and guideline revision that could support this process.

Quality Management System Competency Guidelines

Purpose statement: The competencies in Quality Management System (QMS) address the knowledge, skills, and abilities required for developing a laboratory's culture of quality (Table 1). The essential elements integrate operations, services, and infrastructure into a system that meets applicable regulatory standards, professional guidelines, and customer requirements for ensuring and maintaining quality and continually improving laboratory services.

Introduction: QMS is a systematic approach for ensuring the consistent quality of the tests performed, the products created, the data generated, and the results reported. Operating within a quality system meets the needs and requirements of public health laboratories as well as the expectations of partners, stakeholders, and users (internal and external customers). A QMS is more than quality assurance and quality control — it also includes all the business processes of a laboratory that are required to ensure quality. Adhering to quality standards for laboratory operations helps laboratories generate consistent, reliable, and reproducible data and results.

As the first responsibility of the public health laboratory staff is to provide quality testing and services to support the health of the public and meet the many needs of their customers, this demand for quality is superimposed on all aspects of laboratory operations. As such, a quality management system is the foundation for every other activity within this competency set.

Notes: The structure for this domain is based upon the 12 quality system essentials (33). Multiple additional sources were identified as support documents for this domain (34–40). As the foundational domain for these guidelines, all other competencies should be viewed within its context. However, this domain is systems-oriented. Other domains contain quality-related subcompetencies that address "bench-level" quality indicators and activities and not the creation, maintenance, and evaluation of a quality management system as presented here. The verb "oversees" is used extensively in the Expert level. In this context, "oversees" is a broad term that comprises the many functions related to the management of policies, processes, and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration.

Ethics Competency Guidelines

Purpose statement: The competencies in Ethics address the knowledge, skills, and abilities needed to fulfill basic responsibilities to perform in a collegial and ethical manner within a laboratory setting (Table 2). Ethical professional and scientific behaviors are essential when working in the public health laboratory to help ensure scientific integrity and sustain effective relationships with stakeholders and the public.

Introduction: Ethics are principles or a set of values held by a person or group, i.e., the rules or standards governing the conduct of a person or the conduct of the members of a profession. These principles and rules include characteristics such as personal accountability, maintaining confidentiality, and ensuring the accuracy of testing results. These vital but sometimes unspoken values, standards, and resulting professional and scientific codes of conduct are critical to establishing and maintaining a collegial environment in which scientific integrity is held in the highest regard.

To carry out its mission, the public health laboratory must earn and maintain the public's trust. As diligent stewards of that trust and of public funds, all public health laboratory staff should act decisively and ethically in service to the public's health. Laboratory staff should apply ethical principles in all aspects of their work, including respecting their colleagues, customers, and populations they serve. Individual laboratory staff members should apply ethical principles in decision-making to all aspects of their job performance and take responsibility for outcomes associated with their decisions. Ethics must exist at every level in the organization; and it must be championed by every staff person, not just leadership.

Notes: Multiple sources were identified as support documents for this domain (41–45). This domain is intentionally broad and includes examples of general and scientific ethics and practices in the glossary. It is the responsibility of each organization to further identify and detail the professional and scientific values and characteristics important to them. The General Laboratory Practice, Research, and Management and Leadership domains also include ethics-related competencies.

Management and Leadership Competency Guidelines

Purpose statement: The competencies in Management and Leadership address the knowledge, skills, and abilities related to managing staff (supervision), the science and practice of achieving results using available resources (management), and the process of influencing the actions of a person or group to attain desired objectives (leadership) (Table 3).

Introduction: Management and leadership are distinct and complementary roles, both of which are necessary for the success of an organization. They can be distinguished in a number of ways (46). Leadership establishes the purpose and strategic direction of the organization. Leading involves innovating, influencing, and motivating. Leadership asks "what" and "why" and mainly works with persons and their interrelationships. Management establishes the systems and processes of the organization. Managing involves administering, planning, organizing, and coordinating. Management asks "how" and "when" and mainly works with systems, processes, mechanisms, models, and structures. Leadership challenges and improves accepted policies and processes and ensures alignment with the mission and vision of the laboratory (i.e., strives to do the right things). Management works within accepted administrative policies and processes to accomplish the mission and vision of the laboratory (i.e., strives to do things right). Effective management and leadership are both critical to accomplishing the core functions of public health laboratories (2,3).

All staff members require a certain degree of management and leadership skills. The scope of work performed by public health laboratories is complex and, therefore, requires staff members who have the crucial leadership and management knowledge and skills to be effective in such an environment. Public health laboratories have a great need to develop these skill sets, as there is a severe and continuing shortage of scientists qualified to assume management and leadership positions. This situation is made more challenging because staff members are rarely provided formal training in these areas through degree, fellowship, or other programs.

Notes: Multiple sources were identified as support documents for this domain (4,10,11,14,15,35,37,46,47), which supports all other domains in these guidelines. This domain is intended for all staff, not just those with managerial or leadership positions or job titles. It is sometimes difficult to separate a skill, behavior, or process as belonging exclusively to either management or leadership. As such, leadership subcompetencies are interwoven throughout the domain and are not limited to those within the Leadership competency (MLD 5.00). Ethics-related competencies are included in this domain that correlate with competencies found in the Ethics domain.

Communication Competency Guidelines

Purpose statement: The competencies in Communication address the knowledge, skills, and abilities necessary to disseminate information in a clear and concise manner appropriate to a given audience (Table 4). Communication might occur in writing, orally, or nonverbally, and it might take place in person or through electronic means.

Introduction: Communication is the application of written, verbal, and nonverbal methods and resources, either in person or through available technologies, to convey information. Although transmission of information is critical, assurance the information is accurate, clear, tailored to the audience, and prepared with linguistic aptitude and cultural sensitivity is equally important.

Effective internal and external communication is necessary for the optimal operation of the public health laboratory. Internal communication between staff is essential to satisfy the organization's goals and quality management system. External communication is necessary to disseminate public health information and to highlight the importance of laboratory contributions in support of public health. Public health laboratories are often called upon to convey the mission, operational features, and test services (the "why," "how," and "what") of their laboratory. These tasks involve engaging traditional and nontraditional partners and are critical to ensuring continued interest and support of the public health laboratory system.

Notes: Multiple sources were identified as support documents for this domain (14,15,48,49). Communication skills are pervasive throughout other domains, including skills such as writing and instructing. Communicating or reporting test orders and results are not covered here but in the General Laboratory Practice, Chemistry, and Microbiology domains.

Security Competency Guidelines

Purpose statement: The competencies in Security address the knowledge, skills, and abilities necessary to ensure a secure, protected working environment that meets or exceeds applicable regulatory requirements and guidelines (Table 5).

Introduction: Security is a compilation of elements that include physical, operational, information, and staff protection with the intent to safeguard personnel and to protect assets and data from unauthorized access, misuse, loss and/or theft. This is accomplished through the implementation of a comprehensive security management system, founded on accepted practices, that ensures that operations are carried out in an environment that is secure and protected at all times. Each person must consistently carry out their responsibilities to ensure the effective application of security practices.

To meet its mission, the public health laboratory must ensure the security of the environment, infrastructure, staff, and of the samples and sensitive information with which it is entrusted. Thus, the knowledge, skills, and abilities included in this domain must be integrated into all technical and nontechnical aspects of staff members' job performances.

Note: Multiple sources were identified as support documents for this domain (50–52).

Emergency Management and Response Competency Guidelines

Purpose statement: The competencies in Emergency Management and Response address the knowledge, skills, and abilities needed to mitigate, prepare for, respond to, and recover from laboratory-specific emergency events and situations (Table 6).

Introduction: Emergency Management and Response is a four-phase process involving mitigation, preparedness, response, and recovery for emergency events and situations that have a direct impact on laboratory operations and surge testing. This domain recognizes the public health laboratory's mandate to provide emergency response support to external partners. Emergency management and response encompasses events such as natural disasters or public health emergencies, facility or operation failures, in addition to the public health responsibility to detect and respond to real or potential biological, chemical, or radiological threats.

Public health laboratory staff members are responsible for the recognition, response, and management of emergency events and situations directly impacting laboratory operations and surge testing. Staff members provide outreach, training, and communication with the sentinel clinical laboratories, first responders, and other stakeholders as a critical role in jurisdiction-wide emergency management and response.

Notes: Multiple sources were identified as support documents for this domain (21,26,51,53–57). This domain is intended to be used in conjunction with the Safety and Communication domains and is based on the Federal Emergency Management Agency's (FEMA) mission areas for national preparedness (55). Critical activities in each phase frequently overlap. This domain does not address accidents, spills, or other similar occurrences within the laboratory, which are included in the Safety domain.

Workforce Training Competency Guidelines

Purpose statement: The competencies in Workforce Training address the knowledge, skills, and abilities needed to train public health laboratory professionals (Table 7). This includes the design, development, implementation, and evaluation of all types of training.

Introduction: Workforce Training is a process that uses principles of adult learning and instructional design to develop, manage, deliver, and evaluate internal and outreach education and training activities. Although training services and resources can be accessed externally, management should also support internal activities to ensure staff members possess the skills and knowledge to carry out their responsibilities in all aspects of their job performance. This domain provides guidance to staff members on subject matter expertise and project management for the development and delivery of training.

As persons are an organization's most valuable asset, having well-trained staff members at all functional levels improves organizational performance and ensures the success of the laboratory in providing services to address public health concerns.

Notes: Sources were identified as support documents for this domain (36,58). This domain is intended for the general laboratory scientist and not solely for education or training specialists or subject matter experts. The competencies apply to all types of training modalities.

General Laboratory Practice Competency Guidelines

Purpose statement: The competencies in General Laboratory Practice address the knowledge, skills, and abilities needed to fulfill basic responsibilities for performing sample analyses within a public health laboratory setting (Table 8).

Introduction: General laboratory practice is the set of foundational knowledge and capabilities needed for the testing of samples across the wide spectrum of scientific and technical activities of public health laboratories. As these practices can be applied in many areas of analysis, they have been consolidated into this domain to minimize, but not eliminate, repetition across the specialized domains and to create a domain that covers testing not specifically encompassed by the Chemistry or Microbiology domains.

These broad practices are central to the performance of laboratory testing. Laboratory scientists, regardless of their specific area of scientific or technical expertise, rely on these skills to accomplish the array of testing in public health laboratories.

Notes: Sources were identified as support documents for this domain (59,60), which is intended for both general and specialized laboratory scientists. This domain is meant to be used in conjunction with specialized domains such as Microbiology, Chemistry, and Research since it includes technical practices not addressed in those domains. The verb "oversees" is used extensively in the Expert level. In this context, "oversees" is a broad term that comprises the many functions related to the management of policies, processes and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration.

Safety Competency Guidelines

Purpose statement: The competencies in Safety address the knowledge, skills, and abilities necessary to ensure a safe working environment that meets or exceeds applicable regulatory requirements and guidelines (Table 9).

This domain comprises five subdomains:

Potential Hazards, which addresses the knowledge, skills, and abilities needed to recognize potential hazards within a given laboratory setting;

Hazard Control, which addresses the knowledge, skills, and abilities needed to support and maintain a health and safety management system to control or prevent workplace hazards;

Administrative Controls, which addresses the knowledge, skills, and abilities needed to develop a laboratory safety program that is compliant with regulatory, accreditation, and licensing requirements;

Communication and Training, which addresses the knowledge, skills, and abilities needed to ensure staff members are informed of all safety hazards through effective communication and the provision of related education and training; and

Documents and Records, which addresses the knowledge, skills, and abilities needed to document activities related to safety policies, processes, and procedures.

Introduction: Safety focuses on the occupational and personal safety of staff members and the environments in which they work. A culture of safety encourages reporting of actual and potential situations which might place staff members and others at risk, openly assesses those risks, and implements redundant systems to keep risk to the absolute minimum. It is essential that leadership and management staff members ensure a comprehensive safety culture for those working in the public health laboratory.

A safety culture is fundamental to ensuring the protection of the laboratory facility, its staff, and the surrounding environment from hazards and risks related to laboratory operations and services. Safety is the background against which all staff members must perform all aspects of their job. A culture of safety recognizes that to err is human, and establishes procedures and processes to minimize errors and avoid harm. To be effective, all staff members are expected to be part of the culture of safety.

This domain is based on the 2011 "Guidelines for Biosafety Laboratory Competency" (26), with the content revised and restructured to fit within this comprehensive set of public health laboratory competencies. This domain supplements and expands upon the 2011 Guidelines. Some reformulation of concepts from the former "Midlevel" and "Senior level" tiers were introduced here to ensure a wider breadth of bench-level and managerial responsibilities. However, the 2011 Biosafety Laboratory Competencies include critical task-level details that could not be captured here due to the directives for competency development that were adopted. The 2011 Guidelines are, therefore, an important companion to this domain.

Note: Multiple sources were identified as support documents for this domain (26,51,52,61–74).

Surveillance Competency Guidelines

Purpose statement: The competencies in Surveillance address the knowledge, skills, and abilities required for the collection and analysis of data to support public health decision making to ensure the health of the community (Table 10). This includes continuous laboratory testing, data compilation, and data dissemination on infectious organisms, chemical analytes, radiological materials, and evidence of hereditary anomalies.

Introduction: Surveillance is the continuous, systematic collection, analysis, and interpretation of health-related data needed for the planning, implementation, and evaluation of public health practice (75). With surveillance, the spread of disease (i.e., any condition that causes injuries, disabilities, disorders, syndromes, infections, or symptoms) is monitored to establish patterns of progression to predict, observe, and minimize the harm caused by the disease. Well-developed surveillance capacity is the foundation on which health departments detect, evaluate, and design effective responses to public health threats. Laboratory information and services are essential to public health surveillance, as the collection, validation, analysis, interpretation, dissemination, and use of laboratory-generated results are crucial to target public health prevention and ensure the health of communities. Public health laboratory scientists and epidemiologists need to work closely to ensure effective population-based disease control and prevention. Effective laboratory reporting to epidemiologists, providers, or other submitters also requires an electronic laboratory reporting (ELR) system that is interoperable with electronic health records and notifiable condition reporting for both care and surveillance.

The public health laboratory plays a unique role in public health surveillance by providing crucial information on the appropriate samples and testing methods, by identifying harmful substances and agents, and by providing the ability to investigate and communicate unusual findings. It is essential for laboratory staff members to understand both their individual role and the laboratory's role in surveillance, testing, reporting, and disease and exposure monitoring.

Notes: Multiple sources were identified as support documents for this domain (15,75–77). Because all public health laboratory testing has a direct or indirect impact on surveillance, this domain is intended for all staff members and not just for persons involved in dedicated surveillance activities.

Informatics Competency Guidelines

Purpose statement: The competencies in Informatics address the knowledge, skills, and abilities needed to systematically apply information science, computer science, and information technology to support public health practice, research, and learning (Table 11).

Introduction: Informatics is a broad field encompassing information science, information technology, algorithms, and social science. In addition to electronic recordkeeping and automated data management, informatics includes such activities as test analyses, clinical decision support, messaging, and knowledge management. Once thought of as a support function, the delivery of laboratory informatics services has now evolved to be a mission-critical and central component of laboratory operations.

Informatics is critically important to the public health laboratory's role in protecting the public from infectious diseases, environmental dangers, and other health threats. Public health laboratory informatics must be cross-cutting and interoperable to support a nationally integrated electronic laboratory reporting (ELR) system and electronic health record (EHR) system. Since all laboratories must rely on informatics capabilities and often have limited access to informaticians or informatics specialists, it is essential that all staff members maintain varying levels of informatics competencies.

Notes: Multiple sources were identified as support documents for this domain (20,78–81). In particular, the competencies defined in this domain are based on the content and framework of a 2013 comprehensive public health laboratory informatics self-assessment tool (78). In turn, this tool was framed on an earlier document (79) outlining consensus on the business requirements of laboratory information management systems. Some of the competencies provided in these guidelines, particularly the Expert level, might appear beyond the reach of the typical bench scientist. While laboratory scientists might initially have competencies limited to the Beginner or Competent level, a long-term goal is to ensure that public health laboratories have within their ranks scientists with competencies at the Proficient and Expert levels. This domain includes paper systems as part of the laboratory information system.

Microbiology Competency Guidelines

Purpose statement: The competencies in Microbiology address the knowledge, skills, and abilities needed to safely and securely detect, identify, and report infectious agents of concern to the public while following the laboratory path of workflow (Table 12).

Introduction: Microbiology is the scientific study of microorganisms and infectious agents as applied to the diagnosis, treatment, and prevention of disease, disability, and death. Microbiology includes the subspecialties of virology, mycology, parasitology, mycobacteriology and bacteriology that are encompassed in the disciplines of clinical, food, and environmental microbiology.

Microbiology is critical to the public health role of detecting and identifying outbreaks, emerging diseases, and biological threats. Public health laboratories serve many public health programs and provide reference and specialized testing that relate to disease control and prevention in the population. The testing services address multiple modes of transmission and include molecular methods for epidemiology and disease surveillance. In addition, public health laboratories provide many specialized tests that are not commercially available.

Notes: Multiple sources were identified as support documents for this domain (26,51,59,61,62,82). This domain is not expected to be all-inclusive of functions performed in every microbiology subspecialty in the laboratory. The General Laboratory Practice and Safety domains are companions to this domain; all are intended to be used together, though some overlap in content exists. The verb "oversees" is used extensively in the Expert level. In this context, "oversees" is a broad term that comprises the many functions related to the management of policies, processes and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration. There is an assumption for the Beginner level, especially with use of the verbs "performs" and "adheres to," that there is a degree of training and supervision still occurring that is providing needed guidance and information (e.g., on why it is critical to perform steps and processes as directed).

Chemistry Competency Guidelines

Purpose statement: The competencies in Chemistry address the knowledge, skills, and abilities needed for the qualitative and quantitative analysis of chemicals of concern to the public in biological and environmental matrices (Table 13).

Introduction: Chemistry is the science of detection, measurement, and characterization of chemicals of public health importance in samples (e.g., human and animal, food and feed, water and soil). Chemistry encompasses numerous subdisciplines in areas of both organic and inorganic testing.

Chemistry programs within public health laboratories provide a first line of defense in the rapid recognition of toxic chemical exposures and also support environmental health and epidemiological programs that investigate human exposures to chemicals in the environment. Chemistry programs also provide a wide array of specialized services related to clinical diagnostics for evaluating individual health, identification of environmental health issues, and investigation of population exposures through epidemiological programs' studies. They also aid in the response to chemical emergencies or chemical terrorism events by providing rapid and definitive testing to identify and quantify chemical agents.

Notes: Sources were identified as support documents for this domain (60,83). This domain is not expected to be all-inclusive of all chemistry-related laboratory activities. The General Laboratory Practice and Safety domains are companions to this domain; all are intended to be used together, though some overlap in content exists. The verb "oversees" is used often in the Expert level. In this context, "oversees" is a broad term that comprises the many functions related to the management of policies, processes and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration. There is an assumption for the Beginner level, especially with use of the verbs "performs" and "adheres to," that there is a degree of training and supervision still occurring that is providing needed guidance and information (e.g., on why it is critical to perform steps and processes as directed).

Bioinformatics Competency Guidelines

Purpose statement: The competencies in Bioinformatics address the knowledge, skills, and abilities needed to collect, classify, and analyze biological and biochemical information through the development and use of computer databases, algorithms, and statistical techniques (Table 14).

Introduction: Bioinformatics is the field of science that bridges the gap between biology, computer science, and information technology by merging them into a single discipline. There are three important subdisciplines within bioinformatics: the development of new algorithms and statistics with which to assess relationships among members of large data sets; the analysis and interpretation of various types of data including nucleotide and amino acid sequences, protein domains, and protein structures; and the development and implementation of tools that enable efficient access and management of different types of information.

Bioinformatics capability and capacity have become progressively more important within public health laboratories because of rapid advances in molecular technologies and laboratory techniques. As a result, the amount of data that a typical laboratory can generate has increased dramatically over the past decade. This increase in data requires new competencies for laboratory scientists to analyze and interpret large datasets, and communicate complex and complete results to audiences of varied backgrounds.

Notes: Sources were identified as support documents for this domain (84,85). This domain is intended for all laboratory scientists in addition to bioinformatics specialists.

Research Competency Guidelines

Purpose statement: The competencies in Research address the knowledge, skills, and abilities needed to conduct a systematic, hypothesis-driven investigation that includes research development, testing, and evaluation designed to advance public health knowledge, methods, and/or practice (Table 15).

Introduction: Research is a systematic investigation designed to develop or contribute to generalizable knowledge. It also includes product or method development, assessment, and evaluation. Scientific research provides information to solve new or existing problems, to reaffirm results of previous work, and to support or develop new hypotheses.

Research is critical to the public health enterprise, as communities are continually challenged with new diseases and unknown environmental public health threats. The public health laboratory community is also challenged by changes in virulence or drug susceptibility of pathogens, which impact exposure investigation and response, and the need for advanced diagnostics and analyses to support surveillance.

Notes: Multiple sources were identified as support documents for this domain (41,44,86,87). This domain is intended for use in conjunction with the General Laboratory Practice and Safety domains. The verb "oversees" is used extensively in the Expert level. In this context, "oversees" is a broad term that comprises the many functions related to the management of policies, processes and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration. This domain does not address areas of assessment and evaluation of laboratory practices, which is included in the Quality Management System and Management and Leadership domains.

Conclusion

These competency guidelines outline the knowledge, skills, and abilities needed by the PHL workforce to fulfill the responsibilities of, and demands on, the PHL system. They were developed with consideration of the diversity and complexity of PHLs. The competencies should serve as a foundation for workforce development efforts to identify and support training standards and performance expectations; develop standardized job descriptions; periodically assess individual staff and organizational capacity; and develop and implement training plans with the competencies as a guide. The competency guidelines might also be used as a framework for developing progressive job series (career ladders) for PHL workers, which has been identified as a significant barrier to worker recruitment and retention (6–8).

CDC and APHL recognize the existence of possible obstacles and challenges that might affect the implementation of these competencies. Although the uses and benefits of implementing the competencies are numerous, their adoption by PHLs might be affected by organizational and resource constraints. Acceptance and adoption of competencies in a workplace require ongoing leadership support for successful assimilation of competencies into human resources processes such as job descriptions or for integration into the curriculum of the laboratory's training and continuing education programs. Because most laboratories' human resource functions are managed by an ancillary department outside the laboratory, a collaborative effort will be needed to weave competencies into the performance management systems and hiring processes. There is also a need to educate laboratory professionals about the value of applying competencies to their daily work and a need for understanding how competencies can be used as a career ladder and management tool. On the basis of experience with the biosafety laboratory competencies published in 2011 (26), it might take several years before competencies are integrated into daily work practices (16). Successful assimilation of these competency guidelines will depend on the resources available to fully adopt and implement them and on the receptivity of laboratory professionals across the spectrum of job positions and titles. Sustained effort in these areas will be critical to strengthening the workforce and its ability to support and manage the national laboratory system.

Acknowledgments

The following persons contributed to this report: Joan Cioffi, PhD, Office of Public Health Preparedness and Response, CDC; subject matter experts from the APHL Workforce Development Committee, other PHL leadership and staff members, CDC, and practitioners from the American Society for Clinical Pathology, the American Society for Clinical Laboratory Science, the Association of Food and Drug Officials, the Association of American Feed Control Officials, the Coordinating Council on the Clinical Laboratory Workforce, the Clinical Laboratory Management Association, and the Clinical and Laboratory Standards Institute; Angela J. Beck, PhD, Matthew L. Boulton, MD, University of Michigan Center of Excellence in Public Health Workforce Studies.

References

BOX. Timeline for development of the competency guidelines August 2012: The CDC/Association of Public Health Laboratories (APHL) Steering Committee for the Public Health Laboratory (PHL) Competencies Project was established. October 2012: A Project Planning Workgroup comprising CDC, APHL, and PHL representatives met to define the scope and structure of the competencies. December 2012: The Development Workgroup conducted a review of published literature and resources, including competency sets for non-PHL audiences. Outlines were crafted for use as a template for each domain. January–April 2013: Eleven Domain Teams developed draft competencies for 14 domains using the expertise of 90 subject matter experts from CDC, APHL, state and local PHLs, academic laboratories, clinical laboratories, the US Department of Agriculture, and other entities. Each Domain Team held regular, facilitated conference calls to develop and refine their competencies. April–November 2013: A Synthesis Workgroup assessed domain gaps and redundancies and harmonized language across domains. November 2013–January 2014: The competencies were vetted by volunteer representatives from external organizations and key stakeholders including PHL representatives, clinical laboratory representatives, APHL, and CDC. December 2013: The Adjudication Process Workgroup, comprising APHL, CDC, and PHL representatives, established the process for the adjudication of reviewer comments by the Domain Teams. January–March 2014: Domain Teams addressed comments received during the vetting period via conference calls. The Ethics domain was crafted as a separate domain, resulting in 15 total domains. April 2014: The Harmonization of Domains Workgroup reviewed major changes made by the Domain Teams to the draft competencies in response to reviewer comments and resolved remaining redundancies and inconsistencies in approach and language among the competency domains. April–July 2014: Small teams from the Harmonization of Domains Workgroup finalized the competency domains. October 2014: The CDC/APHL Steering Committee reviewed the competency guidelines. February 2015: CDC reviewed and approved the final guidelines.

FIGURE. Schematic of competency domains for public health laboratory professionals* Alternate Text: This figure is a triangle showing a schematic of competency domains for public health laboratory professionals. Teams of subject matter experts developed general, cross-cutting technical, and specialized competencies, with a quality management system as the foundation of every activity. The base of the triangle comprises general competencies: Quality Management, followed in a separate tier by Ethics, Management and Leadership, Emergency Management and Response, and Workforce Training. The middle section of the triangle comprises cross-cutting technical competences: General Laboratory Practice, Safety, Surveillance, and Informatics. The apex of the triangle comprises specialized competencies: Microbiology, Chemistry, Bioinformatics, and Research.

TABLE 1. Public health laboratory competency guidelines: Quality Management System (QMS) domain QMS 1.00. Organization: ensures that the laboratory's organizational structure is committed to achieving and maintaining quality* Subcompetency Beginner Competent Proficient Expert QMS 1.01. Commitment to quality Describes quality concepts and good professional practice Demonstrates actions consistent with quality concepts and good professional practice Sustains laboratory quality management system (QMS)* processes and procedures to ensure good professional practice Oversees the development of policies,* processes,* and procedures* for review and maintenance of the QMS QMS 1.02. Organizational structure Identifies the laboratory's organizational structure that ensures quality Explains how the laboratory's organizational structure ensures quality Manages organizational structure to ensure quality Coordinates organizational structure to ensure the QMS is well-integrated into all levels of laboratory operations QMS 1.03. Quality culture Describes the culture, programs, and communication processes regarding quality, safety, and ethical practices* Adheres to the culture, programs, and communication processes regarding quality, safety, and ethical practices Advocates for a culture of quality, safety, and ethics Fosters a culture of quality, safety, and ethics QMS 1.04. Resources Identifies resources used to support the QMS Requests resources to support the QMS Makes resource allocation decisions to support the QMS Ensures the ability to respond to unanticipated needs for resources to support the QMS QMS 1.05. Cost of quality* Describes how cost effective quality measures can improve laboratory performance Analyzes quality measures to evaluate the costs of maintaining quality Develops the procedures to estimate and compare quality costs Creates an action plan to address the impact of quality costs on regulatory compliance, customer* service, and the operating budget

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS) domain QMS 2.00. Customer focus: ensures that customer needs, expectations, and requirements* are consistently met Subcompetency Beginner Competent Proficient Expert QMS 2.01. Customer satisfaction Recognizes the laboratory's internal and external customers Responds to internal and external customer inquiries and feedback Analyzes feedback and satisfaction data from internal and external customers Oversees the system for measuring customer and user satisfaction QMS 2.02. Customer services Describes the customer services provided by the laboratory to meet customer needs, expectations, and requirements Adheres to roles and responsibilities in meeting customer needs, expectations, and requirements Develops procedures to address customer needs, expectations, and requirements Oversees the policies, processes, and procedures for providing customer services that meet customer needs, expectations, and requirements QMS 3.00. Facilities and safety: ensures that the laboratory's physical environment, maintenance, and safety programs* meet applicable requirements Subcompetency Beginner Competent Proficient Expert QMS 3.01. Workplace safety Participates in required workplace training regarding safety and maintenance of the physical environment Manages work area to ensure staff compliance with safety requirements Develops site-specific workplace safety policies and procedures Oversees the policies, processes, and procedures to develop, review, and maintain a safety plan that meets requirements QMS 3.02. Facilities Describes the laboratory design, escape routes, and workplace accommodations Monitors environmental controls* for good laboratory practice and testing capabilities Ensures security and containment of staff, samples,* laboratory supplies, and laboratory equipment* Directs the process and planning for facility design, modification, and renovation QMS 3.03. Waste management Describes waste management policies, processes, and procedures Applies waste management policies, processes, and procedures to activities Trains staff on the waste management plan,* including recycling and disposal methods Ensures the waste management plan follows regulatory requirements QMS 3.04. Emergency management and response Explains own role in emergency event mitigation, preparedness, response, and recovery Trains staff in the emergency management plan for emergency event mitigation, preparedness, response, and recovery Provides input on emergency management and response policies, processes, and procedures Establishes emergency management and response policies, processes, and procedures QMS 4.00. Personnel: ensures recruitment and retention of a qualified, well-trained, and competent workforce Subcompetency Beginner Competent Proficient Expert QMS 4.01. Staff qualification process Describes education, training, and skills required for job performance Describes process required to verify staff qualification and competency Ensures each position has the required competencies, education, training, skills, experience, and where applicable, certification,* and licensure* Designs a process to determine required competencies, education, training, skills, experience and where applicable, certification and licensure for each job title QMS 4.02. Orientation and end-of-employment Participates in orientation and end-of-employment processes Ensures orientation and end-of-employment processes are carried out for each staff person Facilitates orientation and end-of-employment processes Designs an orientation and end-of-employment program QMS 4.03. Training Participates in required training Ensures that training and evaluation are carried out for assigned duties Facilitates training and evaluation processes Oversees the policies, processes, and procedures for the training program

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS) domain QMS 4.00. Personnel: ensures recruitment and retention of a qualified, well-trained, and competent workforce Subcompetency Beginner Competent Proficient Expert QMS 4.04. Competence assessment plan Describes competence assessment plans Participates in the development of an individualized competence assessment plan Evaluates individual competence assessment plans Oversees a competence assessment plan for the organization QMS 4.05. Professional development plan Participates in initial training related to assigned work position Participates in continuing education and professional development opportunities Manages the plan to provide professional development opportunities to all levels of staff Designs a plan to provide professional development opportunities to all levels of staff QMS 4.06. Performance evaluation process Participates in the initial performance evaluation process Participates in the ongoing performance evaluation process Manages the performance evaluation process Establishes a process for periodic performance evaluation QMS 4.07. Recruitment, retention, and succession plans Describes the recruitment and retention plan Participates in recruitment and retention planning Manages the recruitment, retention, and succession plans Develops recruitment, retention, and succession plans to maintain a qualified workforce QMS 5.00. Purchasing and inventory: ensures that requirements for supplies and services are consistently met Subcompetency Beginner Competent Proficient Expert QMS 5.01. Procurement process Describes laboratory procurement process for current work area Participates in laboratory procurement process Manages laboratory procurement process Ensures that laboratory procurement incorporates organizational rules and collaboration with purchasing authorities QMS 5.02. Inventory processes Describes the inventory management processes used in current work area Follows established inventory management processes, including receipt and inspection processes Develops inventory processes for laboratory supplies, reagents, and verification* of performance Oversees inventory management plan QMS 5.03. Evaluation process Describes the process to evaluate and provide feedback to suppliers Executes the process to evaluate and provide feedback to suppliers, consultants, and contractors Develops a process to evaluate the satisfaction with services and products from suppliers, consultants, and contractors Oversees a quality improvement plan for purchasing and inventory QMS 6.00. Laboratory equipment: ensures that laboratory equipment selection, installation, use, maintenance, and troubleshooting meet performance standards Subcompetency Beginner Competent Proficient Expert QMS 6.01. Acquisition and decommissioning Describes the policies, processes, and procedures for equipment acquisition and decommissioning Provides input on the processes and procedures for equipment acquisition and decommissioning Develops the processes and procedures for equipment acquisition and decommissioning Oversees the policies, processes, and procedures for equipment acquisition and decommissioning QMS 6.02. Equipment qualification plan* Describes processes and procedures for equipment installation qualification, operational qualification, and performance qualification Performs equipment installation, operational, and performance qualification procedures Implements the equipment qualification plan Oversees the policies, processes, and procedures regarding the equipment qualification plan

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS) domain QMS 6.00. Laboratory equipment: ensures that laboratory equipment selection, installation, use, maintenance, and troubleshooting meet performance standards Subcompetency Beginner Competent Proficient Expert QMS 6.03. Maintenance process Describes processes and procedures for the maintenance, troubleshooting, and service and repair of equipment Performs procedures for the maintenance, troubleshooting, and service and repair of equipment Develops the processes for equipment maintenance, troubleshooting, and service and repair Oversees the policies, processes, and procedures for equipment maintenance, troubleshooting, service, and repair QMS 6.04. Instrument and equipment calibration Describes calibration of instruments and equipment Performs calibration of instruments and equipment Establishes calibration processes and procedures for instruments and equipment Oversees calibration policies, processes, and procedures for instruments and equipment QMS 7.00. Process management:* ensures that operational processes meet organizational requirements Subcompetency Beginner Competent Proficient Expert QMS 7.01. Workflow† processes Describes workflow processes related to job position and activities Applies workflow processes according to laboratory policies, processes, and procedures Develops evaluation, modification, and design of workflow processes and procedures Oversees the policies, processes and procedures for evaluating and modifying current workflow processes and for developing new workflow processes QMS 7.02. Process control Describes how processes are controlled in work area Participates in process control procedures Develops the process control plan Oversees the process control plan QMS 7.03. Method validation* and performance verification processes Describes method validation and performance verification processes Performs procedures for method validation and performance verification Develops method validation and performance verification processes and procedures Oversees the policies, processes, and procedures for validation of new or modified tests or materials and for verification of existing tests or materials QMS 8.00. Documents* and records:* ensures that there is an effective system to control and manage documents and records Subcompetency Beginner Competent Proficient Expert QMS 8.01. Document management system Describes how the laboratory controls and manages documents Applies the policies, processes, and procedures for controlling and managing documents Develops the policies, processes, and procedures for controlling and managing documents Oversees the document management system to ensure staff compliance with internal policies, external regulations, and accreditation* requirements QMS 8.02. Records management system Describes how the laboratory controls and manages records Applies the policies, processes, and procedures for controlling and managing records Develops the policies, processes, and procedures for controlling and managing records Oversees the record management system to ensure staff compliance with internal policies, external regulations, and accreditation requirements

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS) domain QMS 9.00. Information* management: ensures the confidentiality,* security, and integrity of generated and disseminated information Subcompetency Beginner Competent Proficient Expert QMS 9.01. Confidentiality Describes the policies, processes, and procedures for maintaining confidentiality of laboratory information Complies with policies, processes, and procedures for maintaining confidentiality of internally and externally derived information Develops policies, processes, and procedures for maintaining confidentiality of internally and externally derived information Oversees the policies, processes, and procedures for ensuring confidentiality of information and staff compliance with regulations and guidelines QMS 9.02. Security Describes the policies, processes, and procedures related to securing information related to assigned job tasks Complies with policies, processes, and procedures for securing information Develops policies, processes, and procedures to ensure information is secure Oversees the policies, processes, and procedures for securing information, including audits to meet regulations and guidelines QMS 9.03. Information integrity Describes the policies, processes, and procedures for ensuring integrity of information Complies with policies, processes, and procedures to ensure the integrity of information Develops processes and procedures to ensure the integrity of information Oversees the policies, processes, and procedures to ensure the integrity of information QMS 10.00. Nonconforming event* management: ensures that processes are in place for detecting and managing nonconforming events Subcompetency Beginner Competent Proficient Expert QMS 10.01. Management of nonconforming events (NCEs) Recognizes NCEs Responds to NCEs Investigates NCEs, including the creation of a corrective action plan Oversees the policies, processes, and procedures related to NCEs QMS 10.02. Documentation of NCEs Describes the policies, processes, and procedures to record and report NCEs Reports discovered NCEs Performs analysis of records and reports of NCEs to identify trends Oversees the policies, processes, and procedures to document NCEs and report NCE information to senior management and external entities QMS 10.03. Investigation and root cause analysis* Participates in NCE investigations and root cause analyses Leads the process of investigating NCEs and performing root cause analyses Assesses NCE investigations and root cause analyses to improve processes Oversees the policies, processes, and procedures for investigating NCEs and performing root cause analyses QMS 10.04. Notifications of recalls and technical bulletins Describes the policies, processes, and procedures to address product recalls and technical bulletin notifications Responds to product recalls and technical bulletin notifications Develops processes and procedures to address product recalls and technical bulletin notifications Oversees the policies, processes, and procedures to address product recalls and technical bulletin notifications QMS 11.00. Assessments: ensures that processes are in place to perform internal audits* and external assessments* Subcompetency Beginner Competent Proficient Expert QMS 11.01. Quality assessment* plan Adheres to the quality assessment plan Ensures the application of the quality assessment plan to laboratory operations Develops the quality assessment plan Oversees a comprehensive quality assessment plan QMS 11.02. External assessments Participates in external assessment activities Performs external assessment procedures Develops the processes and procedures to select, enroll, and participate in external assessments Oversees the policies, processes, and procedures related to external assessment QMS 11.03. Internal audits Participates in internal audits Performs internal audit procedures Develops the processes and procedures for internal audits Oversees the policies, processes, and procedures related to internal audits

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS) domain QMS 11.00. Assessments: ensures that processes are in place to perform internal audits* and external assessments* Subcompetency Beginner Competent Proficient Expert QMS 11.04. Quality indicators* Describes the elements of pre-examination,* examination,* and postexamination* quality indicators Employs pre-examination, examination, and postexamination quality indicators Develops processes and procedures for determining pre-examination, examination, and postexamination quality indicators Oversees the policies, processes, and procedures related to developing and assessing quality indicators QMS 11.05. Quality indicator data collection and analysis Describes the policies, processes, and procedures related to collecting and analyzing quality indicator data Complies with policies, processes, and procedures related to collecting and analyzing quality indicator data Develops the processes and procedures for collecting and analyzing quality indicator data Oversees the policies, processes, and procedures related to the collection and analysis of quality indicator data QMS 12.00. Continual improvement: ensures mechanisms for continuous quality improvement Subcompetency Beginner Competent Proficient Expert QMS 12.01. Continuous Quality Improvement (CQI)* program Describes the policies, processes, and procedures related to the CQI program Implements changes identified through the CQI program Develops the processes and procedures of the CQI program Oversees the policies, processes, and procedures related to the quality improvement program QMS 12.02. CQI activities Participates in CQI activities Follows CQI processes and procedures for troubleshooting and documenting required CQI activities Documents staff compliance with CQI activities that support the CQI monitoring, evaluation, and review processes Oversees the policies, processes, and procedures related to CQI activities QMS 12.03. Corrective action* process Describes the policies, processes, and procedures related to corrective action Implements the processes and procedures related to corrective action Develops corrective action processes and procedures to address quality improvement Oversees the policies, processes, and procedures related to corrective action QMS 12.04. Preventive action* Describes the policies, processes, and procedures related to preventive action Implements the processes and procedures related to preventive action Develops the processes and procedures related to preventive action Oversees the policies, processes, and procedures related to preventive action QMS 12.05. Change management* Describes the process to change laboratory policies, processes, and procedures Participates in the process and procedures related to change management Implements the change management process, including communication of changes made to established policies, processes, and procedures Oversees activities related to policy, process, and procedural change management, including evaluation of impact on organizational processes and services

TABLE 2. Public health laboratory competency guidelines: Ethics domain ETH 1.00. Professional code of conduct: adheres to policies* and principles governing professional ethics and rules of conduct when working in a public health laboratory Subcompetency Beginner Competent Proficient Expert ETH 1.01. Personal integrity Aligns personal integrity with organizational culture Exemplifies integrity in interactions and activities Coaches staff in behaviors that exemplify integrity Creates a culture where integrity is the foundation for all interactions and activities ETH 1.02. General ethical practices* Applies ethical principles and professional rules of conduct to the workplace Serves as a role model of ethical behavior by consistently conforming to the highest ethical standards and practices Ensures staff compliance with policies and procedures related to ethical principles and professional rules of conduct Oversees the policies, processes,* and procedures* related to ethical principles and professional rules of conduct ETH 1.03. Stewardship of resources Acts as a good steward of public funds and resources Identifies methods to improve stewardship of resources Ensures that the use of public funds and resources meet the policies for stewardship Oversees the policies, processes, and procedures to ensure the environment supports excellence in the stewardship of resources ETH 2.00. Scientific code of conduct: adheres to policies and principles governing scientific ethics* and rules of conduct when working in a public health laboratory Subcompetency Beginner Competent Proficient Expert ETH 2.01. Scientific integrity* Verifies scientific integrity of test results and findings Instructs others in policies, processes, and procedures regarding scientific integrity of test results and findings Ensures staff compliance with policies and procedures regarding scientific integrity of all results and findings Oversees the policies, processes and procedures to ensure practices are consistent with guidelines on scientific integrity ETH 2.02. Scientific ethics Applies scientific ethics and rules of conduct to the workplace Serves as a role model of scientific ethical behavior and rules of conduct by consistently conforming to the highest scientific standards and practices Ensures staff compliance with policies and procedures related to scientific ethics and rules of conduct Oversees the policies, processes, and procedures related to scientific ethics and rules of conduct

TABLE 3. Public health laboratory competency guidelines: Management and Leadership domain MLD 1.00. General management: ensures sound management of laboratory operations Subcompetency Beginner Competent Proficient Expert MLD 1.01. Mission, vision, and values Contributes to activities that support the mission, vision, and values of the laboratory Explains the relationships between activities that support the mission, vision, and values Exemplifies the mission, vision and values for the laboratory Develops the mission, vision and values for the laboratory MLD 1.02. Organizational structure Describes the organizational structure of the laboratory Coordinates laboratory program* structure to meet organizational needs Adapts organizational structure to meet the laboratory's mission and directives for laboratory programs Oversees a process* to ensure organizational structure meets the laboratory's mission and directives for laboratory programs MLD 1.03. Laws and regulations for laboratory operation Complies with laws and regulations related to laboratory operations Coordinates program activities according to laws and regulations related to laboratory operations Manages laboratory programs consistent with laws and regulations related to laboratory operations Ensures that laboratory programs are consistent with federal, state, and local laws and regulations MLD 1.04. Technical operations management Works collaboratively on technical and operational planning Implements technical and operational plans Develops processes and procedures to manage technical operations Oversees the policies,* processes, and procedures* related to the development and evaluation of technical operations MLD 1.05. Emergency management and response Describes emergency management policies and procedures Operates within assigned roles when carrying out emergency management and response duties Manages the emergency management and response plan at the programmatic level Oversees laboratory-wide emergency management and response

TABLE 3. (Continued) Public health laboratory competency guidelines: Management and Leadership domain MLD 1.00. General management: ensures sound management of laboratory operations Subcompetency Beginner Competent Proficient Expert MLD 1.06. Analytical and operational services Describes the processes for introducing improved analytical and operational services Participates in improvement of analytical and operational services Manages the improvement of analytical and operational services Oversees funding and stakeholder relationships needed to implement and improve analytical and operational laboratory services MLD 1.07. Quality* testing and services Describes quality principles Explains the importance of providing quality laboratory testing and services Evaluates the quality of services for continued quality improvement Oversees the policies, processes, and procedures to ensure the quality of laboratory testing and services MLD 1.08. Customer* service Supports customer service needs Evaluates customer service satisfaction and trends Identifies strategies and activities to improve customer service Oversees the policies, processes, and procedures to ensure the laboratory maintains a customer focus MLD 1.09. Project management* Uses basic project management concepts* and tools Trains staff on project management techniques Directs the management of projects at the programmatic level Oversees project management across the laboratory MLD 1.10. Program effectiveness Contributes data for program effectiveness monitoring and evaluation Analyzes data to assist in the monitoring and evaluation of program effectiveness Directs activities to monitor and evaluate the effectiveness of laboratory programs Oversees the policies, processes, and procedures regarding the measurement, analysis, and improvement of program effectiveness MLD 2.00. Policy development: ensures the development, implementation, and review of internal policies Subcompetency Beginner Competent Proficient Expert MLD 2.01. Internal policy development Describes concepts pertinent to developing internal policies Compiles important issues, lists of stakeholders, and various options and solutions for internal policy development Prepares internal policies based on evaluation of short- and long-term consequences of potential policies Oversees the internal policy development process MLD 2.02. Internal policy implementation Complies with documented internal policies and guidelines Implements internal policies for a laboratory program Ensures staff compliance with laboratory-wide policies Oversees internal policy implementation and staff compliance MLD 2.03. Internal policy review Reviews internal policies for revisions and updates Develops amendments or updates to internal policies Evaluates internal policies Oversees the review process for internal policies MLD 3.00. Financial management: ensures sound financial management Subcompetency Beginner Competent Proficient Expert MLD 3.01. Budgets Complies with budgetary guidelines Monitors staff compliance to the budget Reconciles budget, expenditures, and income Oversees budgets, including development and staff compliance with agency and legislative mandates MLD 3.02. Revenue and income Describes revenue sources associated with individual activities Tracks revenue and income for a laboratory program Manages revenue and income for the laboratory Ensures that necessary revenue and income is secured MLD 3.03. Expenditures Adheres to guidelines and limits for expenditures Tracks expenditures for a laboratory program Ensures staff compliance with guidelines and limits for expenditures Oversees the policies, process, and procedures related to the cost of operations

TABLE 3. (Continued) Public health laboratory competency guidelines: Management and Leadership domain MLD 3.00. Financial management: ensures sound financial management Subcompetency Beginner Competent Proficient Expert MLD 3.04. Financial management process Uses designated financial management tools Integrates financial management tools for a laboratory program Optimizes the financial management system for the laboratory Oversees the policies, processes, and procedures related to financial management and fiduciary responsibility MLD 3.05. Resource management Uses workplace resources efficiently Optimizes use of laboratory program resources Manages resources for the laboratory Oversees the policies, processes, and procedures related to resource management MLD 4.00. Human resource management: ensures effective management of human resources Subcompetency Beginner Competent Proficient Expert MLD 4.01. Human resource policies Complies with human resource rules and requirements* Enforces human resource requirements and policies Manages human resource requirements and policies Oversees the policies, processes, and procedures related to the human resource system MLD 4.02. Equal Employment Opportunity (EEO)* process Describes the EEO process Promotes EEO requirements and policies Manages EEO requirements and policies Oversees the policies, processes, and procedures related to EEO in the human resource system MLD 4.03. Position descriptions Provides input into job description content Evaluates position descriptions for congruency with job functions Manages the development and implementation processes for position descriptions Oversees a system of position description development and implementation to maximize staff competence and meet operational requirements MLD 4.04. Staff licensure* Describes the basic education, skills and certifications* for laboratory staff licensure requirements Maintains a process to ensure that staff meet licensure requirements Performs ongoing gap analysis to address staff licensure requirements Ensures staff compliance with licensure laws and regulations MLD 4.05. Competency assessment Participates in competency assessments Manages the competency assessment program Evaluates the competency assessment program Ensures that staff competence levels are commensurate with job functions MLD 4.06. Performance feedback Participates in communications with peers and supervisors regarding performance Integrates performance feedback into work routines Monitors staff progress on agreed-upon performance parameters Ensures that a system is in place that values honest and open communication about performance MLD 4.07. Performance appraisal process Describes how the formal performance appraisal process impacts laboratory operations Administers performance appraisals Evaluates effectiveness of the performance appraisal process in improving laboratory productivity and practice Oversees the continuous improvement of the performance management system MLD 4.08. Conflict resolution Identifies the need for management intervention in conflict resolution Resolves conflicts in a fair and equitable manner Integrates mechanisms to support cooperation and manage conflict across the laboratory Oversees the policies, processes, and procedures to ensure the fair and equitable resolution of conflicts

TABLE 3. (Continued) Public health laboratory competency guidelines: Management and Leadership domain MLD 4.00. Human resource management: ensures effective management of human resources Subcompetency Beginner Competent Proficient Expert MLD 4.09. Progressive discipline Describes the steps of the progressive discipline process Administers progressive discipline Analyzes the use of progressive discipline within the laboratory Ensures that the progressive discipline system is used to mitigate disciplinary issues MLD 4.10. Professional development Participates in professional development activities Recommends professional development activi