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        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 (13). 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 (68) 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 (911).

        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 (1215). 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 (1218).

        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 (14,15,1924), 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 115). 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 (3440). 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 (4145). 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 (5052).

        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 (21,26,51,5357). 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 (26,51,52,6174).

        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 (15,7577). 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 (20,7881). 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.

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        * A list of all of the members of the various committees, teams, and workgroups appears beginning on page 93 of this report.


        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*

        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.

        * Teams of subject matter experts develop general, cross-cutting technical, and specialized competencies, with a quality management system as the foundation of every activity. 

        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

        * This term is defined in Appendix B.

        Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured in the report of results, including pre-examination, examination, and postexamination procedures.


        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

        * This term is defined in Appendix B.


        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 activities

        Assesses professional development gaps to ensure and support staff competency development

        Oversees the policies, processes, and procedures to encourage and address professional development

        MLD 4.11. Staff advancement

        Explains the policies and procedures related to staff advancement

        Recommends staff for advancement

        Develops criteria for staff advancement

        Ensures that staff function in roles commensurate with experience, skill set, and proficiency

        MLD 4.12. Succession planning

        Recognizes the importance of succession planning

        Implements staff development plans that align with the laboratory's succession plan

        Develops succession plans that consider current and future needs

        Oversees the policies, processes, and procedures related to the creation and implementation of succession plans

        MLD 5.00. Leadership: models leadership behavior

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MLD 5.01. Ethical practices* and professional code of conduct

        Applies ethical principles and a professional code of conduct to the workplace

        Serves as a role model of ethical and professional behavior by consistently conforming to the highest standards and practices

        Ensures staff compliance with the policies and procedures related to ethical practices and a professional code of conduct

        Fosters the policies, processes, and procedures related to ethical practices and a professional code of conduct

        MLD 5.02. Communication

        Employs active communication skills

        Communicates information and feedback to colleagues and management staff

        Ensures the open and frequent exchange of communication between laboratory staff

        Fosters a culture of open and frequent communication

        MLD 5.03. Teamwork and collaboration

        Describes the value of collaboration in the workplace

        Collaborates with team members within a laboratory program

        Leads cross-functional teams to accomplish projects

        Creates a workplace environment that encourages teamwork and collaboration

        MLD 5.04. Diversity* culture

        Explains the value of having a diverse workforce

        Promotes a diverse workforce

        Develops programs that support a culture of diversity

        Fosters a culture where diversity is valued

        MLD 5.05. Staff engagement*

        Participates in activities to support the laboratory's goals

        Implements activities that support staff engagement

        Develops programs that support a culture of staff engagement

        Fosters a culture of staff engagement and commitment

        MLD 5.06. Staff recognition

        Participates in staff recognition programs

        Evaluates the effectiveness of staff recognition programs

        Develops staff recognition programs

        Fosters a culture that ensures staff recognition

        MLD 5.07. Coaching* and mentoring*

        Describes the benefits of coaching and mentoring

        Develops a pool of potential coaches and mentors for staff

        Establishes coaching and mentoring programs

        Fosters a culture where coaching and mentoring are deeply-rooted

        MLD 5.08. Critical thinking*

        Develops basic critical thinking skills

        Applies critical thinking to develop effective solutions to problems

        Leads critical thinking activities to achieve improvements in laboratory processes

        Fosters an environment that integrates critical thinking


        TABLE 3. (Continued) Public health laboratory competency guidelines: Management and Leadership domain

        MLD 5.00. Leadership: models leadership behavior

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MLD 5.09. Systems thinking*

        Describes systems thinking

        Applies systems thinking when approaching projects and problem solving

        Incorporates systems thinking into directing laboratory operations

        Fosters an environment that integrates systems thinking

        MLD 5.10. Strategic thinking*

        Describes strategic thinking

        Provides input into strategic thinking and decision-making processes

        Integrates strategic thinking into decisions and long-term planning regarding laboratory operations

        Fosters an environment that integrates strategic thinking

        MLD 5.11. Change management*

        Describes the value of change

        Implements change management initiatives within a laboratory program

        Leads the development of change management initiatives with the laboratory

        Fosters a culture that continuously assesses change opportunities for sustaining the mission

        MLD 5.12. Advocacy

        Educates external stakeholders on the mission, vision, and activities of the laboratory

        Collaborates with external stakeholders

        Identifies gaps in engagement with external stakeholders to support the activities of the laboratory

        Develops strategies to engage external stakeholders to accomplish the mission, vision, and activities of the laboratory

        MLD 5.13. External policy development

        Describes impacts of external policies related to the organization's mission

        Communicates with stakeholders to exchange policy input

        Promotes external policy development to support the organization's mission and vision

        Fosters relationships with strategic partners to secure laboratory-inclusive policies consistent with the organization's mission and vision

        MLD 5.14. Promotion of the health of populations

        Recognizes the need for partnerships to promote the health of populations

        Identifies potential partnerships to promote the health of populations

        Facilitates participation of key stakeholders to promote the health of populations

        Fosters partnerships with key stakeholders to promote the health of populations affected by laboratory services

        * This term is defined in Appendix B.


        TABLE 4. Public health laboratory competency guidelines: Communication domain

        COM 1.00 Communication techniques: deploys formal written and oral communication strategies

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 1.01. Written communication

        Identifies key messages for written communication

        Applies logical structure* to written communications

        Incorporates tools to organize and present detailed or complex information*

        Establishes content, style, tone, and form for written messages according to target audience

        COM 1.02. Oral communication

        Identifies key messages for oral communication

        Applies language and tone in oral communications tailored to target audience

        Selects communication methods* tailored to target audience

        Establishes content, style, tone, and form for oral messages tailored to target audience

        COM 2.00. Active listening* skills: displays active listening skills when interacting with others

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 2.01. Dialogue exchange

        Provides undivided attention to the other participants in a dialogue

        Summarizes the dialogue to show understanding

        Provides feedback based on the dialogue summary

        Facilitates dialogue exchange through paraphrasing and clarification of critical points

        COM 2.02. Contextual clues

        Exhibits open posture and facial expression to engage the other participants in a dialogue

        Applies range of body language cues to enhance the exchange

        Exhibits active listening during the dialogue exchange

        Incorporates multiple behaviors of engagement during dialogue exchanges

        COM 2.03. Respectful exchange

        Defers judgment during dialogue exchanges

        Provides counterpoints while being respectful of disagreements

        Coaches others in techniques of respectful exchange

        Facilitates respectful dialogue among participants in the exchange


        TABLE 4. (Continued) Public health laboratory competency guidelines: Communication domain

        COM 3.00. Comprehension of materials: demonstrates comprehension of written documents* and directions

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 3.01. Reading comprehension

        Follows written directions

        Applies knowledge acquired from written text to situations

        Adapts concepts from written text for use in new situations

        Extrapolates information from written text to develop new ideas that enhance work processes*

        COM 4.00. Communication technology:* utilizes technology to communicate information to internal and external partners

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 4.01. Technology capability

        Describes the laboratory's and partner's technological capabilities

        Selects laboratory's technology options to align with partner's capabilities

        Evaluates existing and potential technology to align with partner's capabilities

        Establishes technology policies* that integrate with the partner's capabilities

        COM 4.02. Use of technology

        Describes employer's policies and procedures* for sharing information

        Uses designated technology for sharing information

        Manages technology policies and procedures used for sharing information

        Evaluates the effectiveness of the technology used for sharing information

        COM 5.00. Communication professionalism: ensures professionalism in communication with customers* and stakeholders

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 5.01. Professional attitude

        Uses tone of voice and language tailored to interactions with customers and stakeholders

        Displays professional demeanor in all situations with customers and stakeholders

        Monitors interactions with customers and stakeholders to ensure they are conducted professionally

        Establishes policies for professional customer and stakeholder interactions

        COM 5.02. Information exchange

        Provides information based on policies and procedures to meet the needs of customers and stakeholders

        Determines information needs through collaboration with customers and stakeholders

        Ensures that information exchange policies, processes, and procedures are followed to meet the needs of the customers and stakeholders

        Develops overarching system for exchange of information to meet the needs of customers and stakeholders

        COM 5.03. Information sharing opportunities

        Shares information as directed

        Selects information to share

        Develops information to share

        Creates opportunities for sharing information

        COM 6.00. Professional reports: prepares professional written reports and oral presentations

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 6.01. Written reports

        Organizes information for written reports

        Creates drafts of written reports

        Revises written reports

        Establishes policies, processes, and procedures for written reports

        COM 6.02. Oral presentations

        Organizes information for oral presentations

        Creates drafts of oral presentations

        Revises oral presentations

        Establishes policies, processes, and procedures for oral presentations

        COM 7.00. Risk communication:* applies emergency and risk communication principles and techniques to explain information to targeted audiences

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 7.01. Risk communication plan

        Describes the risk communication process

        Adheres to the risk communication plan

        Ensures staff compliance with the risk communication plan

        Establishes policies, processes, and procedures related to the risk communication plan


        TABLE 4. (Continued) Public health laboratory competency guidelines: Communication domain

        COM 7.00. Risk communication:* applies emergency and risk communication principles and techniques to explain information to targeted audiences

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 7.02. Emergency information

        Lists basic emergency information for target audience

        Identifies specific emergency information for target audience

        Develops emergency information and messages tailored to target audience

        Collaborates with agency leaders and partners to deliver emergency information and messages tailored to target audience

        COM 7.03. Empathetic risk communication

        Describes empathetic risk communication concepts

        Delivers empathetic messaging in high-risk situations or emergencies

        Creates empathetic messaging in high-risk situations and emergencies

        Evaluates empathetic messaging for high-risk situations and emergencies

        COM 8.00. Public health laboratory value: promotes the value of the public health laboratory

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 8.01. Public relations

        Describes impact of the work of the public health laboratory and system

        Coordinates opportunities for promoting the public health laboratory and system

        Identifies opportunities to promote the public health laboratory and system

        Develops opportunities to promote the public health laboratory and system

        COM 8.02. Communication to educate and inform

        Supports the development and distribution of communication materials about the public health laboratory

        Presents communication materials to explain the importance of the public health laboratory

        Develops communication materials to explain the importance of the public health laboratory

        Manages the policies, processes, and procedures regarding communication materials to explain the importance of the public health laboratory

        COM 8.03. Storytelling

        Shares approved public health laboratory stories

        Incorporates use of stories when communicating the impact of public health laboratory work

        Develops stories that convey information highlighting the impact of public health laboratory work

        Evaluates the impact of storytelling in promoting the public health laboratory

        COM 8.04. Marketing strategy

        Participates in marketing strategies

        Implements the marketing strategy for the public health laboratory

        Manages the marketing strategy for the public health laboratory

        Oversees the marketing strategy for the public health laboratory

        COM 9.00. Media relations: works with the media to provide information about public health laboratories and public health issues

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        COM 9.01. Media relations policies and strategies

        Adheres to agency media relations policies and procedures

        Identifies situations where agency media relations policies and strategies apply

        Monitors the application of agency media relations policies and strategies

        Oversees media relations policies and strategies

        COM 9.02. "Plain talk"*

        Describes the value of using "plain talk"

        Applies "plain talk" during public and media interactions

        Develops "plain talk" language for media and public communications

        Translates highly technical concepts using "plain talk" for media and public communications

        COM 9.03. Key messages

        Describes the value of using key messages

        Applies key messages during public and media interactions

        Develops key messages for media and public communications

        Oversees delivery of key messages on complicated, high-risk topics

        * This term is defined in Appendix B.


        TABLE 5. Public health laboratory competency guidelines: Security domain

        SEC 1.00. Risk mitigation: ensures that the laboratory's risk mitigation plan* meets organizational goals, regulatory requirements,* and established standards

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 1.01. Security concepts*

        Describes security concepts

        Applies security concepts in support of organizational goals

        Interprets security concepts to adapt policies* and procedures* to support organizational goals

        Develops security policies, processes,* and procedures, including security standards

        SEC 1.02. Risk assessment

        Describes the risk assessment process and procedures

        Identifies assets,* vulnerabilities, and potential threats for incorporation into risk analyses

        Manages the risk assessment process

        Develops policies, processes, and procedures regarding risk assessment

        SEC 1.03. Risk mitigation plans

        Describes the policies and procedures regarding risk mitigation plans

        Applies risk mitigation plans

        Manages the implementation of risk mitigation plans

        Develops policies, processes, and procedures regarding risk mitigation planning and implementation

        SEC 1.04. Risk mitigation plan reporting

        Describes policies, processes, and procedures for risk mitigation plan reporting

        Implements processes and procedures for risk mitigation plan reporting

        Develops procedures based on established processes for risk mitigation plan reporting

        Develops policies, processes, and procedures for risk mitigation plan reporting

        SEC 2.00. Security plan:* ensures that the laboratory's security plan meets organizational goals, regulatory requirements, and established standards

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 2.01. Security plans

        Recognizes security risks documented in the security plan

        Recommends elements to be included in the security plan to address risks

        Designs laboratory's security plan in collaboration with subject matter experts

        Advises organizational leadership on the security plan, including acceptability of identified risks

        SEC 2.02. Security plan implementation

        Describes security plan elements applicable to job

        Implements the security plan

        Evaluates the objectives and functions of the security system

        Advises organizational leadership on selecting security strategies to protect assets and on monitoring the performance of the security plan


        TABLE 5. (Continued) Public health laboratory competency guidelines: Security domain

        SEC 2.00. Security plan:* ensures that the laboratory's security plan meets organizational goals, regulatory requirements, and established standards

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 2.03. Security operations

        Describes the policies, processes, and procedures for maintaining security

        Monitors security operations

        Manages security operations to ensure defined protection measures are based on the degree of risk

        Oversees security operations

        SEC 2.04. Inventory records* related to security plans

        Completes inventory records to comply with the laboratory's security plan

        Audits inventory records

        Creates tools to manage inventory records

        Develops policies, processes, and procedures to manage inventory records

        SEC 2.05. Security incident* response

        Reports security incidents

        Evaluates reported security incidents

        Implements processes and procedures related to security incident response and reporting

        Develops policies, processes, and procedures for security incident response and reporting

        SEC 3.00. Physical security: ensures that physical security is maintained

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 3.01. Physical security infrastructure*

        Describes the physical security infrastructure

        Trains staff on policies, processes, procedures, and related regulations regarding physical security infrastructure

        Solves difficult and complex physical security problems

        Directs the resolution of major conflicts in physical security policy and program objectives

        SEC 3.02. Physical security access controls*

        Describes physical security access control policies, processes, procedures, and systems

        Applies physical security access control procedures and systems

        Manages the implementation of physical security access control policies, processes, procedures, and systems

        Advises organizational authorities on methods for enhancing effectiveness and efficiency of physical security access control policies, processes, procedures, and systems

        SEC 4.00. Personnel security program:* implements a personnel security program to meet organizational goals, regulatory requirements, and established standards

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 4.01. Personnel security concepts*

        Describes personnel security concepts

        Addresses problems or questions involving personnel security concepts

        Interprets personnel security concepts to adapt processes and procedures to support organizational goals

        Develops policies, processes, and procedures that incorporate personnel security concepts into personnel security program

        SEC 4.02. Personnel security program

        Complies with the laboratory's personnel security program

        Implements the personnel security program

        Solves difficult and complex personnel security problems

        Directs the resolution of major conflicts in personnel security policy and program objectives

        SEC 4.03. Investigations

        Collects information* for personnel security investigations

        Analyses actions regarding personnel security matters requiring investigation

        Determines actions to be taken on personnel security investigations

        Develops policies, processes, and procedures related to personnel security investigations


        TABLE 5. (Continued) Public health laboratory competency guidelines: Security domain

        SEC 5.00. Information security:* ensures that information security meets organizational goals, regulatory requirements, and established standards

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 5.01. Information security

        Describes policies, processes, and procedures related to information security

        Applies information security concepts, including principles of confidentiality, integrity, and availability (CIA)*

        Interprets information security concepts to adapt policies, processes, and procedures to support organizational goals

        Develops policies, processes, procedures, and organizational standards for information security to meet organizational goals

        SEC 5.02. Risk identification and prioritization

        Describes the risks associated with the laboratory's sensitive information* or technology related to the job being performed

        Identifies risks associated with the laboratory's sensitive information and technology, including the methods of control

        Implements processes and procedures for prioritizing risks associated with the laboratory's sensitive information and technology, including the methods of control

        Develops polices, processes, and procedures for identifying, prioritizing, and controlling sensitive information and technology

        SEC 6.00. Transportation security program: implements a transportation security plan*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SEC 6.01. Transport security

        Complies with transport security policies, processes, and procedures

        Audits transport records

        Creates transport security procedures

        Establishes policies and processes to specify which materials need designated levels of transport security

        * This term is defined in Appendix B.

        The process of identifying risks to organizational assets (including staff) and operations (including mission, functions, image, and reputation); includes threat and vulnerability analyses and is the fundamental tool to help select the right risk mitigation measures (e.g., engineered controls, standard policies and procedures) to achieve an acceptable level of security.


        TABLE 6. Public health laboratory competency guidelines: Emergency Management and Response domain

        EMR 1.00. Mitigation of emergency events: mitigates emergency events

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        EMR 1.01. Risk assessment*

        Recognizes potential vulnerabilities and risks in their work area

        Assesses potential vulnerabilities and risks in the organization

        Develops the plan to reduce and ensure against risks in the organization

        Manages the policies, processes, and procedures to reduce and ensure against risks in the organization

        EMR 1.02. Incident response plan

        Describes the incident response plan

        Implements the incident response plan while maintaining safety and security of staff and facilities

        Verifies staff compliance with the incident response plan while ensuring the safety and security of staff and facilities

        Manages facility-wide implementation of the incident response plan

        EMR 1.03. Emergency situation recognition

        Recognizes emergencies and other incidents in their work area that should be reported

        Recognizes emergencies and other incidents in the organization that should be reported

        Evaluates staff's ability to recognize emergencies and other incidents that should be reported

        Creates an environment that supports the recognition and reporting of emergencies

        EMR 1.04. Emergency alarms

        Recognizes significance of alarms

        Instructs others on the significance of alarms

        Evaluates staff's knowledge of alarm significance

        Collaborates with persons and agencies to develop site-specific or unique alarm systems

        EMR 1.05. Laboratory assets important during an emergency

        Describes the assets in their work area

        Inventories the assets in the facility

        Identifies the assets in the facility

        Manages the assets in the facility

        EMR 1.06. Evaluation of emergency events

        Summarizes the emergency evaluation process

        Assesses emergencies to determine the extent of each incident

        Interprets data from evaluation of emergencies to develop specific response to each incident

        Shares findings of the evaluation of, and responses to, emergency events with stakeholders to enhance mitigation


        TABLE 6. (Continued) Public health laboratory competency guidelines: Emergency Management and Response domain

        EMR 2.00. Preparation for emergency events: prepares for emergency events

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        EMR 2.01. Preparation for emergency events

        Explains the laboratory's emergency response plan and Continuity of Operations Plan (COOP)

        Assists with development and implementation of the laboratory's emergency response plan and COOP

        Manages development and implementation of the emergency response plan and COOP for an individual area of responsibility

        Oversees laboratory's emergency response plan, including implementation of the COOP with external partners

        EMR 2.02. Incident command system (ICS)

        Demonstrates awareness of the ICS by completing a FEMA-approved introductory course

        Completes higher-level FEMA-approved courses to explain the operation and management of the ICS

        Implements the ICS by completing high-level FEMA-approved courses and internal training courses and exercises

        Serves at a leadership level in the ICS

        EMR 2.03. Emergency response training

        Participates in emergency response training, exercises, and drills

        Contributes to the development of emergency response training, exercises, and drills

        Conducts emergency response training, exercises, and drills in collaboration with stakeholder agencies

        Oversees the collaboration with stakeholder agencies to sponsor and conduct training, exercises, and drills, ensuring proper resources are available

        EMR 2.04. Emergency notification

        Describes requirements for notification of emergencies and other incidents according to organizational plans and policies

        Implements organizational plans and policies for notification of emergencies and other incidents

        Develops internal policies and procedures for notification of emergencies and other incidents

        Oversees the collaboration with stakeholders and agencies to develop and implement plans and policies for notification of emergencies and other incidents

        EMR 2.05. Identification of key partners

        Describe partners and their relationships with the institution

        Interacts with partners on staff

        Engages partners to sustain relationships and ensure effective response

        Develops new partnerships to ensure effective emergency response

        EMR 2.06. Execution of agreements

        Describes emergency agreements between the institution and other partners

        Updates agreements with partners to ensure emergency response capability

        Trains staff on agreements in place to ensure emergency response capability

        Negotiates agreements between partner organizations to ensure emergency response capability

        EMR 2.07. Emergency preparedness and response networks

        Explains how the laboratory interacts with emergency preparedness and response networks

        Describes the plans, policies and procedures the institution has in place to prepare for and respond to a public health emergency

        Develops the organizational plans, policies and procedures to prepare for and respond to a public health emergency

        Oversees the collaboration with emergency preparedness and response networks to develop and implement plans, policies, and procedures to prepare for and respond to a public health emergency

        EMR 3.00. Responding to emergency events: responds to emergency events

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        EMR 3.01. Situational briefing

        Participates in meetings and conference calls to receive information on the situation

        Prepares information on the situation

        Facilitates the briefing of key stakeholders to create situational awareness

        Manages implementation of COOP measures and ICS activation

        EMR 3.02. ICS activation

        Performs position responsibilities as assigned

        Produces information and documentation for briefings

        Confirms staff are available with proper qualifications and capabilities

        Establishes organization's ICS structure, reporting procedures, and chain of command

        EMR 3.03. Emergency evacuation

        Locates emergency evacuation routes and assembly areas

        Uses emergency evacuation routes and assembly areas

        Instructs staff during evacuation

        Manages emergency evacuation and assembly


        TABLE 6. (Continued) Public health laboratory competency guidelines: Emergency Management and Response domain

        EMR 3.00. Responding to emergency events: responds to emergency events

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        EMR 3.04. Hazardous spill response

        Recognizes hazardous spills or potential exposures

        Complies with procedures for responding to hazardous spills or potential exposures

        Instructs staff on proper response to hazardous spills or potential exposures

        Manages response to hazardous spills or potential exposures

        EMR 3.05. Emergency decontamination

        Describes emergency decontamination and exposure prevention policies and procedures

        Complies with emergency decontamination and exposure prevention policies and procedures

        Instructs staff on policies, processes, and procedures for emergency decontamination and exposure prevention

        Manages emergency decontamination and exposure prevention policies, processes, and procedures

        EMR 3.06. Surge capacity

        Describes circumstances for, and varying degrees of surge

        Adjusts workflow§ to ensure timeliness of diagnostic testing in collaboration with surge partners

        Identifies creative strategies to manage surge or overflow testing

        Implements a management system that promotes flexibility and maximizes the ability to deliver surge capacity

        EMR 3.07. Emergency communication plan

        Describes the emergency communication plan and the policies and procedures for receiving and disseminating information with emergency response partners and/or public

        Complies with the emergency communication plan and the policies and procedures for receiving and disseminating information with emergency response partners and/or public

        Ensures rapid and secure communications with emergency response partners and/or public during emergencies and surge incidents

        Manages the emergency communication plan and the policies, processes, and procedures for securely receiving and disseminating information with emergency response partners and the public during emergencies and surge incidents

        EMR 4.00. Recovering from emergency events: recovers from emergency events

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        EMR 4.01. Short-term recovery

        Follows established plans to resume normal operations after an emergency event

        Implements plans to resume normal operations after an emergency event

        Determines whether staff and facilities are able to return to normal operations after an emergency event

        Manages re-opening and/or continuation of routine services

        EMR 4.02. After Action Review (AAR)

        Describes the AAR process

        Participates in AAR process

        Assists with developing the final AAR

        Oversees the AAR process

        EMR 4.03. Long-term recovery

        Lists improvements to laboratory plans based on the AAR

        Identifies improvements to laboratory plans and operations based on the AAR

        Implements improvements to laboratory plans and operations based on the AAR

        Develops recommendations to improve laboratory plans and operations based on the AAR along with internal and external partners and stakeholders

        EMR 4.04. Financial considerations

        Lists costs relative to response and recovery activities

        Explains costs relative to response and recovery activities

        Determines financial and staff resources required to facilitate laboratory's response and recovery

        Verifies financial and staff resources are in place to facilitate laboratory's response and recovery

        EMR 4.05. Legal and regulatory issues

        Describes legal and regulatory requirements for managing emergency events

        Implements legal and regulatory requirements for managing emergency events

        Assesses staff compliance with legal and regulatory requirements related to the managing of emergency events

        Oversees staff compliance with legal and regulatory requirements related to the managing of emergency events

        * The process of identifying risks to organizational assets (including staff) and operations (including mission, functions, image, and reputation); includes threat and vulnerability analyses and is the fundamental tool to help select the right risk mitigation measures (e.g., engineered controls, standard policies and procedures) to achieve an acceptable level of security.

        This term is defined in Appendix B.

        § Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured in the report of results, including pre-examination, examination, and postexamination procedures.


        TABLE 7. Public health laboratory competency guidelines: Workforce Training domain

        WFT 1.00. Content: gathers training content

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 1.01. Needs assessment*

        Supports needs assessment activities

        Conducts needs assessments

        Develops needs assessment tools

        Prioritizes training needs based on needs assessments

        WFT 1.02. Adult learning methodologies

        Explains adult learning methodologies

        Selects principles and methodologies which underpin adult learning

        Integrates principles of adult learning for use in designing training

        Ensures that adult learning principles are applied in designing training

        WFT 1.03. Subject matter expertise

        Employs subject matter knowledge in order to train entry-level staff

        Implements established science and technology content

        Develops emerging science and technology content

        Collaborates with national and international scientific communities to create new knowledge on subject matters

        WFT 1.04. Training topics

        Researches emerging training topics

        Implements training for emerging training topics

        Designs training for emerging training topics

        Identifies emerging training topics with national and international scientific communities

        WFT 1.05. Incorporation of subject matter expertise into training activities

        Explains requirements* for the use of subject matter experts

        Collaborates with subject matter experts to gather content

        Develops new processes* to capture subject matter expertise

        Identifies emerging processes to capture subject matter expertise

        WFT 2.00. Training design: designs training

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 2.01. Instructional design*

        Explains instructional design principles

        Recognizes the instructional design principles in existing training activities

        Applies instructional design principles to develop a new training activity

        Evaluates instructional design and training modalities* throughout the entire menu of training for the organization

        WFT 2.02. Learning objectives

        Explains learning objective concepts and training activities

        Develops training activities around existing learning objectives

        Creates learning objectives for new training activities

        Evaluates whether learning objectives were written following industry guidelines

        WFT 2.03. Training modalities

        Identifies different types of training modalities

        Implements the modality for training

        Selects the modality for the training

        Provides vision and guidance for training modalities


        TABLE 7. (Continued) Public health laboratory competency guidelines: Workforce Training domain

        WFT 2.00. Training design: designs training

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 2.04. Cultural awareness

        Explains cultural awareness and its importance as it relates to developing training activities

        Applies cultural awareness principles when designing training activities

        Evaluates the incorporation of cultural awareness principles into training activities

        Ensures incorporation of cultural awareness principles into training activities

        WFT 2.05. Instructional materials preparation

        Assembles instructional materials

        Prepares instructional materials for existing programs

        Develops instructional materials for new programs that are aligned with the type of training activity and modality

        Incorporates industry-wide instructional materials into the training program

        WFT 2.06. Training materials application

        Uses pre-existing training materials to design simple training

        Integrates multiple types of training materials into training design

        Develops training materials from industry resources

        Evaluates training materials from industry resources

        WFT 2.07. Training exercises

        Delivers exercises within a training session

        Integrates individual training lessons, including experiential exercises

        Evaluates training exercises

        Designs integrated training exercises with partners

        WFT 2.08. Formative assessment*

        Explains formative assessment

        Employs formative assessments

        Creates formative assessments

        Evaluates effectiveness of formative assessments

        WFT 2.09. Continuing education

        Explains the requirements of the continuing education provider

        Follows continuing education provider requirements when conducting training

        Selects continuing education provider for new learning activities

        Oversees the continuing education provider process

        WFT 3.00. Delivery set-up: manages the logistics of set-up for training delivery

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 3.01. Equipment preparation for training delivery

        Operates equipment needed to deliver training

        Troubleshoots training equipment

        Ensures that equipment capability aligns with the training requirements

        Oversees processes for upgrading training equipment

        WFT 3.02. eLearning*

        Tests eLearning courses

        Creates supporting materials or content for storyboards

        Develops storyboards for new courses using subject matter expert materials

        Ensures that eLearning delivery systems are available

        WFT 3.03. Learning environment*

        Provides support for learning environment processes

        Manages processes of the learning environment

        Develops processes to manage the learning environment

        Oversees the processes for the learning environment

        WFT 4.00. Training delivery: applies principles of learning to training implementation and delivery

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 4.01. Learning preferences and styles

        Explains presentation materials for different learning preferences and styles

        Differentiates presentation materials to address learning preferences and styles

        Develops presentation materials to address learning preferences and styles

        Creates strategies to address learning preferences and styles

        WFT 4.02. Presentation engagement

        Explains the most effective presentation tools and techniques

        Uses the most effective presentation tools and techniques

        Ensures implementation of the most effective presentation tools and techniques

        Oversees presentation engagement strategies


        TABLE 7. (Continued) Public health laboratory competency guidelines: Workforce Training domain

        WFT 5.00. Training evaluation: evaluates learner knowledge and skill development

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 5.01. Training evaluation process*

        Lists the steps the organization undertakes for training program evaluation

        Carries out the evaluation steps for standard training evaluations for routine courses

        Develops training evaluation tools* for a new activity

        Oversees the evaluation of the training process for the organization

        WFT 5.02. Delivery of the evaluation

        Contributes to development of a training assessment rubric* to ensure training outcomes are met

        Implements the training assessment rubric to ensure training outcomes are met

        Creates a training assessment rubric to ensure training outcomes are met

        Evaluates the training assessment rubric to ensure training outcomes are met

        WFT 5.03. Training reports*

        Gathers data as directed for summative training reports

        Compiles tracking data into summative training reports

        Develops summative training reporting tools

        Interprets summative data from reports for delivery to stakeholders

        WFT 5.04. Training activity effectiveness

        Shares training activity observations with supervisor

        Assesses participants' achievement of training objectives

        Recommends improvements based on evaluation data from training assessment tools

        Implements improvements to the professional development activities of the laboratory

        WFT 5.05. Continuous improvement of the training program

        Participates in continuous improvement activities

        Identifies activities leading to the continuous improvement of a training plan

        Facilitates activities leading to the continuous improvement of a training plan

        Develops a training program improvement plan based on program evaluation

        WFT 6.00. Marketing: markets training opportunities

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        WFT 6.01. Marketing

        Participates in the marketing of training

        Composes content for marketing materials

        Develops organizational marketing plan for training

        Manages the training marketing plan

        * This term is defined in Appendix B.


        TABLE 8. Public health laboratory competency guidelines: General Laboratory Practice domain

        GEN 1.00. General technical and laboratory practice knowledge: demonstrates general knowledge and skills related to the scientific and technical components of laboratory testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 1.01. General scientific and laboratory concepts and theories

        Applies basic scientific and laboratory concepts and theories* related to the specific testing that is conducted in work area

        Instructs others in concepts and theories related to the specific testing that is conducted in work area

        Ensures that accepted concepts and theories are applied to laboratory testing

        Oversees that laboratory practices are in accordance with accepted scientific and laboratory concepts and theories

        GEN 1.02. Mathematical and statistical concepts and practices

        Applies fundamental mathematical and statistical concepts and practices in work area

        Instructs others in fundamental mathematical and statistical concepts and practices

        Ensures appropriate utilization of mathematical and statistical concepts and practices

        Oversees the policies,* processes,* and procedures* regarding the use of mathematical and statistical concepts and practices

        GEN 1.03. Scientific and technological advances

        Reads scientific and technical literature relevant to own work

        Discusses scientific and technical advances relevant to own work

        Integrates scientific and technical advances into laboratory operations

        Critiques scientific and technological advances to evaluate possible impact for the laboratory

        GEN 1.04. Technical skills

        Applies basic laboratory techniques to laboratory testing

        Integrates basic laboratory techniques into standard operating procedures* and new laboratory practices

        Ensures that staff are properly trained in the performance of technical skills

        Oversees the application of technical skills to laboratory practices

        GEN 1.05. Troubleshooting

        Identifies routine problems related to technical duties and responsibilities

        Resolves routine technical problems with methods, procedures, and laboratory equipment,* including documenting corrective action

        Resolves complex technical problems with methods, procedures, and laboratory equipment, including documenting corrective action

        Oversees the policies, processes, and procedures related to troubleshooting technical problems

        GEN 1.06. Model laboratory practices*

        Applies knowledge of model laboratory practices

        Instructs others in model laboratory practices

        Implements model laboratory practices

        Manages policies, processes, and procedures to ensure staff comply with model laboratory practices


        TABLE 8. (Continued) Public health laboratory competency guidelines: General Laboratory Practice domain

        GEN 1.00. General technical and laboratory practice knowledge: demonstrates general knowledge and skills related to the scientific and technical components of laboratory testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 1.07. Documentation

        Documents actions and results using established paper or electronic systems

        Instructs others in use of paper or electronic methods or systems for documentation

        Ensures utilization of established paper and electronic documentation methods or systems

        Oversees the policies, processes, and procedures for the creation and use of paper and electronic methods or systems for documentation

        GEN 1.08. 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 effective stewardship of resources

        GEN 1.09. Scientific ethics*

        Applies scientific ethics and rules of conduct to the workplace

        Serves as a role model, consistently conforming to the highest scientific standards and practices

        Ensures staff compliance with the 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

        GEN 2.00. Reagent use and storage: adheres to policies and principles regarding the use and storage of laboratory reagents and supplies

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 2.01. Use and storage of reagents and supplies

        Adheres to policies, processes, and procedures for use and storage of reagents and supplies

        Instructs staff in use and storage of reagents and supplies

        Ensures staff compliance with policies, processes, and procedures for use and storage of reagents and supplies

        Oversees the use and storage of reagents and supplies

        GEN 2.02. Reagent preparation

        Adheres to policies, processes, and procedures for preparing reagents

        Instructs staff in preparing reagents

        Ensures staff compliance with policies, processes, and procedures for reagent preparation

        Oversees the policies, processes, and procedures for reagent preparation

        GEN 3.00. Equipment use: adheres to policies and principles regarding the use, maintenance, and calibration of laboratory equipment

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 3.01. Equipment operation

        Adheres to policies, processes, and procedures for operating laboratory equipment

        Instructs staff in the operation of laboratory equipment

        Ensures staff compliance with policies, processes, and procedures for the operation of laboratory equipment

        Oversees the policies, processes, and procedures for the operation of laboratory equipment

        GEN 3.02. Equipment maintenance

        Performs routine system checks and maintenance

        Instructs staff in procedures to ensure equipment function

        Determines need for repair or replacement of laboratory equipment

        Oversees the policies, processes, and procedures for the maintenance, repair, and replacement of laboratory equipment

        GEN 3.03. Instrument and equipment calibration

        Performs calibration of routine instruments and equipment

        Performs calibration of complex instruments and equipment

        Develops processes and procedures for calibration of instruments and equipment

        Oversees the policies, processes, and procedures for calibration of instruments and equipment

        GEN 3.04. Preventive maintenance and calibration records*

        Documents maintenance and calibration activities

        Inspects preventive maintenance and calibrations records for completeness

        Evaluates the preventive maintenance and calibration records

        Oversees the preventive maintenance and calibration program


        TABLE 8. (Continued) Public health laboratory competency guidelines: General Laboratory Practice domain

        GEN 4.00. Pre-examination:* performs steps in the pre-examination phase of testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 4.01. Sample management*

        Follows policies, processes, and procedures for the management of samples*

        Instructs others in policies, processes, and procedures for sample management

        Monitors staff compliance with established sample management policies, processes, and procedures

        Oversees sample management policies, processes, and procedures

        GEN 5.00. Examination:* performs steps in the examination phase of testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 5.01. Sample analyses

        Performs sample analyses

        Instructs staff in sample analyses

        Ensures staff compliance with policies, processes, and procedures for sample analyses

        Oversees the policies, processes, and procedures related to sample analyses

        GEN 5.02.Testing workflow

        Adheres to policies, processes, and procedures for testing workflow

        Instructs staff in policies, processes, and procedures regarding testing workflow

        Ensures staff compliance in following established testing workflow

        Oversees the policies, processes and procedures that optimize and improve testing workflow

        GEN 5.03. Quality control (QC)* analysis

        Performs QC activities

        Interprets QC data prior to reporting results

        Examines QC data over time to establish QC ranges and limits

        Oversees the policies, processes, and procedures related to QC activities, including staff compliance

        GEN 6.00. Postexamination:* performs steps in the postexamination phase of testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 6.01. QC evaluation

        Assembles QC data for evaluation

        Evaluates QC data for a given data reporting period

        Ensures staff compliance with established policies, processes, and procedures for QC evaluation activities

        Oversees the policies, processes, and procedures related to QC evaluation activities

        GEN 6.02. Test analysis and results interpretation

        Assembles test data for review and action

        Analyzes test data

        Interprets complex or ambiguous results

        Oversees the policies, processes, procedures, and algorithms related to data analysis and results interpretation

        GEN 6.03. Results reporting and data release

        Adheres to policies, processes, and procedures related to reporting and release of examination results and notifiable results*

        Instructs staff in the policies, processes, and procedures related to reporting and release of examination results and notifiable results

        Ensures staff compliance with policies, processes, and procedures related to reporting and release of examination results and notifiable results

        Oversees the policies, processes, and procedures related to reporting and release of examination results and notifiable results to partners

        GEN 6.04. Turnaround time (TAT)

        Performs laboratory testing and reporting within specified or expected TAT

        Monitors TAT performance

        Identifies process efficiencies to improve TAT

        Oversees the policies, processes, and procedures related to TAT

        GEN 6.05. Quality assurance (QA)*

        Explains the differences between QA and QC

        Collects data for reporting on QA indicators and processes

        Evaluates QA indicator data

        Oversees the policies, processes, and procedures related to QA


        TABLE 8. (Continued) Public health laboratory competency guidelines: General Laboratory Practice domain

        GEN 7.00. Regulatory compliance: complies with regulations and guidelines governing laboratory testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        GEN 7.01. Regulatory compliance

        Complies with regulatory requirements* and guidelines related to laboratory testing

        Instructs staff on regulatory requirements and guidelines related to laboratory testing

        Ensures staff compliance with regulatory requirements and guidelines related to laboratory testing

        Oversees the policies, processes, and procedures regarding regulatory requirements and guidelines related to laboratory testing

        GEN 7.02. Proficiency testing* (PT) and alternative assessment*

        Performs PT and alternative assessment

        Reviews PT and alternative assessment results

        Monitors to ensure the PT and alternative assessment program meets regulatory requirements

        Oversees the policies, processes, and procedures related to PT and alternative assessments

        GEN 7.03. Proficiency testing (PT) and alternative assessment reporting

        Reports PT and alternative assessment

        Reviews submissions of PT and alternative assessment results

        Ensures staff compliance with reporting of PT and alternative assessment results

        Oversees the policies, processes, and procedures related to PT and alternative assessment reporting

        GEN 7.04. Method validation* and performance verification*

        Participates in performance of method validation and performance verification

        Compiles results of method validation and performance verification

        Evaluates method validation and performance verification results

        Oversees the policies, processes, and procedures related to method validation and performance verification

        GEN 7.05. Protected information*

        Complies with policies, processes, and procedures regarding protected information

        Instructs staff in policies, processes, and procedures regarding protected information

        Ensures staff compliance with policies, processes, and procedures regarding protected information

        Oversees that organizational policies, processes, and procedures related to protected information align with laws and regulatory requirements and guidelines

        * This term is defined in Appendix B.

        Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured in the report of results, including pre-examination, examination, and postexamination procedures.


        TABLE 9. Public health laboratory competency guidelines: Safety domain

        Safety subdomain: potential hazards

        SPH 1.00. Physical environment: works safely in the physical environment of the laboratory facility*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SPH 1.01. Physical hazards* in the laboratory facility

        Describes the physical hazards in the laboratory facility

        Recognizes new physical hazards in the laboratory facility

        Assesses staff knowledge of the physical hazards in the laboratory facility

        Evaluates the laboratory facility for physical hazards

        SPH 1.02. Control measures* to be used when physical hazards are present

        Describes control measures to be used when physical hazards are present in the laboratory facility

        Implements control measures to be used when physical hazards are present in the laboratory facility

        Ensures staff knowledge of control measures to be used when physical hazards are present in the laboratory facility

        Establishes the control measures to be used when physical hazards are present in the laboratory facility

        SPH 1.03. Work practices* to be used when physical hazards are present

        Describes work practices to be used when physical hazards are present in the laboratory facility

        Implements work practices to be used when physical hazards are present in the laboratory facility

        Ensures that staff implement the established work practices when physical hazards are present in the laboratory facility

        Establishes the work practices to be used when physical hazards are present in the laboratory facility


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: potential hazards

        SPH 2.00. Biological materials:* works safely with biological materials in the laboratory

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SPH 2.01. Biological materials used in the laboratory

        Lists the biological materials in the laboratory

        Distinguishes biohazardous materials* from nonbiohazardous materials in the laboratory

        Manages the inventory of biological materials to ensure it is complete and updated

        Establishes the policies,* processes,* and procedures* for implementing a biological materials inventory system

        SPH 2.02. Hazards associated with the biological materials handled in the laboratory

        Describes hazards associated with the biological materials handled in the laboratory

        Recognizes hazards associated with new biological materials used in laboratory procedures

        Assesses staff knowledge of the hazards associated with biological materials used in laboratory procedures

        Ensures that staff are skilled in describing and recognizing hazards associated with the biological materials used in the laboratory

        SPH 2.03. Control measures to be used when working with biological materials

        Describes the control measures to be used when working with biological materials

        Implements the control measures to be used when working with biological materials

        Ensures that staff implement the established control measures when working with biological materials

        Establishes the control measures to be used when working with biological materials

        SPH 2.04. Work practices to be used when working with biological materials

        Describes the work practices to be used when working with biological materials

        Implements the work practices to be used when working with biological materials

        Ensures that staff implement the established work practices when working with biological materials

        Establishes the work practices to be used when working with biological materials

        SPH 2.05. Hazards associated with laboratory procedures

        Describes hazards associated with the laboratory procedures employed

        Trains staff in the hazards associated with the laboratory procedures employed

        Manages the hazards associated with laboratory procedures

        Ensures that staff are capable of recognizing, training, and managing the hazards associated with laboratory procedures

        SPH 3.00. Research animals:* works safely with research animals

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SPH 3.01. Hazards associated with research animals

        Describes hazards associated with working with research animals

        Identifies hazards associated with the particular species of animals used in the laboratory's research

        Assesses staff knowledge of the hazards associated with the particular species of animals used in the laboratory's research

        Ensures that staff are skilled in describing and recognizing hazards associated with the research animals used in the laboratory's research

        SPH 3.02. Route of exposure* to infectious agents in the animal care setting

        Describes possible route(s) of exposure to infectious agents in relation to animal procedures

        Identifies the possible route(s) of exposure to infectious agents in relation to the animal procedures used in the laboratory or animal facility

        Assesses staff knowledge of the hazards associated with the animal procedures used in the laboratory or animal facility

        Evaluates possible route(s) of exposure to infectious agents in relation to the animal procedures used in the laboratory and animal facilities

        SPH 3.03. Control measures to be used when working with research animals

        Describes control measures to be used when working with research animals

        Implements control measures to be used when working with research animals

        Ensures that staff implement the established control measures when working with research animals

        Establishes the control measures to be used when working with research animals

        SPH 3.04. Work practices to be used when working with research animals

        Describes work practices to be used when working with research animals

        Implements work practices to be used when working with research animals

        Ensures that staff implement the established work practices when working with research animals

        Establishes the work practices to be used when working with research animals


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: potential hazards

        SPH 4.00. Chemical materials:* works safely with chemical materials in the laboratory

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SPH 4.01. Chemicals used in the laboratory

        Identifies chemicals used in the laboratory

        Distinguishes hazardous chemicals* from nonhazardous chemicals in the laboratory

        Manages the chemical inventory to ensure it is complete and updated

        Establishes the policies, processes, and procedures for implementing a chemical inventory system

        SPH 4.02. Hazards associated with chemicals used in the laboratory

        Describes hazards associated with chemicals used in the laboratory

        Recognizes hazards associated with new chemicals used in the laboratory

        Assesses staff knowledge of the hazards associated with chemicals used in the laboratory

        Ensures that staff are skilled in describing and recognizing hazards associated with chemicals used in the laboratory

        SPH 4.03. Control measures to be used when working with chemicals in the laboratory

        Describes control measures to be used when working with chemicals as documented in the laboratory's Chemical Hygiene Plan*

        Implements established control measures when working with chemicals according to the laboratory's Chemical Hygiene Plan

        Ensures that staff implement the established control measures when working with chemicals in compliance with the laboratory's Chemical Hygiene Plan

        Establishes the laboratory's Chemical Hygiene Plan, including specific control measures to be used when working with chemicals

        SPH 4.04. Work practices to be used when working with chemicals in the laboratory

        Describes the work practices to be used when working with chemicals as documented in the laboratory's Chemical Hygiene Plan

        Implements established work practices when working with chemicals according to the laboratory's Chemical Hygiene Plan

        Ensures that staff implement established work practices when working with chemicals in compliance with the laboratory's Chemical Hygiene Plan

        Establishes the laboratory's Chemical Hygiene Plan, including specific work practices to be used when working with chemicals

        SPH 5.00. Radiological materials:* works safely with radiological materials in the laboratory

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SPH 5.01. Radiological materials used in the laboratory

        Lists the radiological materials used in the laboratory

        Describes the characteristics of the radiological materials used in the laboratory

        Manages the inventory of radiological materials to ensure it is complete and updated

        Establishes the policies, processes, and procedures for implementing a radiological materials inventory system

        SPH 5.02. Hazards associated with the use of radiological materials

        Describes the hazards associated with radiological materials used in the laboratory

        Recognizes hazards associated with new radiological materials used in the laboratory

        Assesses staff knowledge of the hazards associated with radiological materials used in the laboratory

        Ensures that staff are skilled in describing and recognizing the hazards associated with radiological materials used in the laboratory

        SPH 5.03. Control measures to be used when working with radiological materials

        Recognizes control measures to be used when working with radiological materials in the laboratory

        Implements control measures to be used when working with radiological materials in the laboratory

        Ensures that staff implement established control measures when working with radiological materials in the laboratory

        Establishes, in collaboration with radiation safety staff, the control measures to be used when working with radiological materials in the laboratory

        SPH 5.04. Work practices to be used when working with radiological materials

        Describes work practices to be used when working with radiological materials in the laboratory

        Implements work practices to be used when working with radiological materials in the laboratory

        Ensures that staff implement established work practices when working with radiological materials in the laboratory

        Establishes, in collaboration with radiation safety staff, the work practices to be used when working with radiological materials in the laboratory

        SPH 5.05. Radiation monitoring devices*

        Describes monitoring devices for the radiological materials used in the laboratory

        Demonstrates operation and use of monitoring devices for the radiological materials used in the laboratory

        Ensures the operation and use by staff of radiation monitoring devices

        Evaluates use and suitability of monitoring devices for the radiological materials used in the laboratory


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: hazard control*

        SHC 1.00. Engineering controls:* implements intervention strategies to control hazards by systematically minimizing, isolating, or removing hazards from the workplace

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 1.01. Engineering controls

        Describes engineering controls

        Employs engineering controls to eliminate or reduce targeted laboratory hazards

        Develops standard operating procedures (SOPs)* and work instructions that incorporate engineering controls

        Ensures the implementation of policies, processes, and procedures related to engineering control design, creation, and use

        SHC 1.02. Training on engineering controls

        Completes required training before using engineering controls

        Trains staff on engineering controls

        Develops required training for engineering controls

        Ensures that training is adequate and appropriate for the engineering controls used in the laboratory

        SHC 1.03. Function verification* and maintenance of engineering controls

        Describes function verification, maintenance, and troubleshooting procedures for engineering controls

        Performs function verification, maintenance, and troubleshooting processes and procedures for engineering controls

        Manages the procedures for function verification, maintenance, and troubleshooting for engineering controls

        Develops policies, processes, and procedures to ensure function verification, maintenance, and troubleshooting for engineering controls

        SHC 1.04. Malfunction of engineering controls

        Recognizes when engineering controls are compromised, malfunctioning, or nonfunctioning, and the resulting reporting requirements*

        Implements procedures to address and report when engineering controls are compromised, malfunctioning, or nonfunctioning

        Manages processes and procedures for addressing and reporting situations in which engineering controls are compromised, malfunctioning, or nonfunctioning

        Develops policies, processes, and procedures for remediation and reporting of engineering control malfunctions to ensure minimal exposure and release of targeted hazards

        SHC 2.00. Safe work practices: designs work practices and procedures to minimize exposure to hazards and to adhere to regulatory requirements

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 2.01. Good housekeeping procedures*

        Describes good housekeeping procedures

        Practices good housekeeping procedures

        Develops processes and procedures related to the establishment and maintenance of good housekeeping

        Oversees the implementation of policies, processes, and procedures related to good housekeeping

        SHC 2.02. Personal hygiene procedures*

        Describes personal hygiene procedures

        Complies with personal hygiene procedures

        Develops personal hygiene procedures

        Ensures staff adherence to personal hygiene policies, processes, and procedures

        SHC 2.03. Safety practices and procedures

        Describes proper work practices and procedures

        Uses proper work practices and procedures

        Develops proper work practices and procedures

        Ensures staff knowledge and use of proper work practices and procedures

        SHC 2.04. Work schedules

        Describes how adherence to own scheduled work activities and tasks minimizes exposure

        Monitors staff adherence to established work schedules and assigned tasks

        Implements procedures to ensure scheduling of work activities and/or workers' tasks minimize staff exposure levels

        Designs processes and procedures to ensure scheduling of work activities and/or workers' tasks minimize staff exposure levels


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: hazard control*

        SHC 3.00. Personal Protective Equipment (PPE):* employs the selection, use, and care of personal protective equipment while being continually mindful of its limitations

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 3.01. PPE selection

        Describes appropriate PPE and its limitations for jobs assigned

        Selects appropriate PPE for jobs assigned

        Develops procedures for the appropriate selection of PPE

        Ensures staff knowledge of procedures for the appropriate selection of PPE

        SHC 3.02. PPE use

        Describes specific PPE and its limitations for use with each laboratory procedure

        Uses specific PPE for each laboratory procedure

        Determines procedures for use of specific PPE

        Ensures staff compliance with procedures for use of specific PPE

        SHC 3.03. PPE inspection

        Describes pre-and postinspection procedures for PPE

        Implements pre-and postinspection procedures for PPE

        Develops pre-and postinspection procedures for PPE

        Ensures staff knowledge of pre-and postinspection procedures for PPE

        SHC 4.00. Systems to track hazards: establishes a system to detect and to control or eliminate the underlying causes of hazards or exposures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 4.01. Hazard reporting, tracking, and investigation

        Describes the procedures for reporting hazardous conditions

        Implements procedures for reporting and tracking all hazards

        Develops procedures to report, track and investigate hazards in their workspace

        Ensures staff compliance with reporting, tracking, and investigating hazards in the workplace

        SHC 5.00. Preventive maintenance: conducts regular maintenance to ensure effective functioning of laboratory equipment* and to extend the life of equipment

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 5.01. Planned maintenance

        Performs required preventive maintenance functions

        Complies with processes and procedures to ensure equipment continues to function effectively

        Implements the processes and procedures to ensure equipment continues to function effectively

        Develops the policies, processes, and procedures to ensure equipment continues to function effectively

        SHC 5.02. Corrective maintenance

        Describes troubleshooting methods to determine whether equipment is malfunctioning and the cause

        Complies with processes and procedures to ensure equipment repairs

        Implements the processes and procedures to ensure equipment repairs

        Develops the policies, processes, and procedures to ensure repairs are conducted in accordance with organizational safety and health procedures

        SHC 6.00. Decontamination* and laboratory waste management: establishes a laboratory waste management plan* that adheres to federal, state, and local regulations

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 6.01. Decontamination of laboratory waste

        Describes procedures for spill cleanup and decontamination of laboratory waste

        Implements procedures for spill cleanup and decontamination of laboratory waste

        Manages procedures for spill cleanup and decontamination of laboratory waste

        Develops policies, processes, and procedures for spill cleanup and decontamination of laboratory waste

        SHC 6.02. Segregated waste categorization* and handling

        Describes procedures for laboratory waste categorization and handling

        Implements procedures for laboratory waste categorization and handling

        Manages procedures for laboratory waste categorization and handling

        Ensures staff compliance with laboratory waste categorization and handling policies, processes, and procedures

        SHC 6.03. Treatment and disposal

        Describes procedures for disposal and treatment of laboratory waste

        Implements procedures for disposal and treatment of laboratory waste

        Manages procedures for disposal and treatment of laboratory waste

        Ensures staff compliance with policies, processes, and procedures for disposal and treatment of laboratory waste


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: hazard control*

        SHC 6.00. Decontamination* and laboratory waste management: establishes a laboratory waste management plan* that adheres to federal, state, and local regulations

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SHC 6.04. Waste reduction

        Describes procedures for laboratory waste reduction

        Implements procedures for laboratory waste reduction

        Manages procedures for laboratory waste reduction

        Ensures staff compliance with policies, processes, and procedures for laboratory waste reduction

        SHC 6.05. Regulated waste* access

        Describes procedures for preventing public access to regulated waste

        Implements procedures for preventing public access to regulated waste

        Manages procedures for preventing public access to regulated waste

        Ensures staff compliance with policies, processes, and procedures for preventing public access to regulated waste

        SHC 6.06. Waste management issues and problems

        Describes procedures for reporting and responding to issues or problems regarding laboratory waste management

        Implements procedures for reporting and responding to issues or problems regarding laboratory waste management

        Develops procedures to ensure that issues or problems regarding laboratory waste management are reported and addressed

        Ensures staff compliance with policies, processes, and procedures to address laboratory waste management issues or problems

        SHC 6.07. Monitoring and evaluation

        Describes procedures for monitoring the laboratory waste management plan

        Implements procedures for monitoring the laboratory waste management plan

        Develops procedures for monitoring the laboratory waste management plan

        Ensures staff compliance with policies, processes, and procedures for monitoring the laboratory waste management plan

        Safety subdomain: administrative controls*

        SAC 1.00. Safety program* management: manages the laboratory safety program

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SAC 1.01. Safety program

        Complies with the safety program requirements for the jobs performed

        Ensures staff compliance with safety program requirements

        Implements the safety program and related training programs

        Ensures that comprehensive safety policies, processes, and procedures are developed as part of the safety program

        SAC 1.02. Program audits

        Participates in audits of the safety program

        Conducts audits of the safety program

        Designs safety program audits

        Evaluates the safety program audit results to identify problem areas

        SAC 1.03. Safety inspections

        Explains the importance of safety inspections

        Participates in safety inspections

        Conducts safety inspections

        Ensures staff compliance with safety inspections

        SAC 1.04. Program evaluation

        Provides feedback on the safety program

        Collects data relating to the effectiveness of the safety program

        Prepares evaluation reports for the safety program

        Designs evaluation reports for the safety program

        SAC 2.00. Guideline and regulation compliance: ensures staff compliance with guidelines and regulations

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SAC 2.01. Regulatory requirements and guidelines

        Describes current regulatory requirements and guidelines governing the safe performance of laboratory procedures

        Complies with current regulatory requirements and guidelines governing the safe performance of laboratory procedures

        Instructs staff on current regulatory requirements and guidelines governing the safe performance of laboratory procedures

        Ensures staff compliance with current regulatory requirements and guidelines governing the safe performance of laboratory procedures

        SAC 2.02. Institutional safety committees*

        Describes institutional safety committees

        Complies with institutional safety committee requirements

        Participates in a leadership role on institutional safety committees

        Ensures staff compliance with institutional safety committee requirements


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: administrative controls*

        SAC 3.00. Risk management: manages risks through systematic practices to evaluate, minimize, or eliminate them

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SAC 3.01. Risk assessment

        Describes the risk assessment process

        Implements control measures identified in risk assessments

        Manages the risk assessment process

        Oversees the policies, processes, and procedures related to risk assessment to ensure controls are appropriate for activities, agents and materials used in laboratory

        SAC 3.02. Incident* reporting

        Reports any incidents, including near-misses

        Reviews reports of incidents to identify root causes and problems

        Conducts routine monitoring of staff compliance regarding incident reporting

        Designs policies, processes, and procedures for reporting and performing root-cause analyses of incidents

        SAC 4.00. Occupational health and medical surveillance: complies with occupational health and medical surveillance policies

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SAC 4.01. Vaccination program

        Describes the organization's vaccination program

        Identifies staff eligible to participate in the vaccination program

        Monitors staff compliance with the vaccination program

        Designs the vaccination program based on exposure risks and regulatory requirements

        SAC 4.02. Medical surveillance program*

        Describes the organization's medical surveillance program

        Identifies staff eligible to participate in the medical surveillance program

        Monitors staff compliance with the medical surveillance program

        Designs the medical surveillance program based on risks encountered and regulatory requirements

        SAC 4.03. Exposure monitoring*

        Describes exposure monitoring procedures

        Complies with exposure monitoring procedures

        Ensures staff compliance with exposure monitoring policies and processes

        Develops the exposure monitoring policies and processes based on risks encountered and regulatory requirements

        SAC 4.04. Occupational incidents

        Identifies the process to obtain medical services after an occupational incident

        Complies with organizational requirements and healthcare provider treatment plans pertaining to an occupational incident

        Prepares summary of occupational incidents

        Develops occupational incident response plan* including regular review and revisions following an occupational incident

        Safety subdomain: communication and training

        SCT 1.00. Hazard communication:* promotes safety through effective hazard communication

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SCT 1.01. Safety signage*

        Describes safety signage and documentation as well as how signage is used to convey information

        Adheres to information and directives in safety signage and documents*

        Evaluates safety signage and document placement and usage

        Ensures staff compliance with safety signage and documents

        SCT 1.02. Safety communication tools

        Describes a variety of communication tools and techniques promoting the work practices employed in own area of responsibility

        Employs a variety of communication tools and techniques promoting the work practices employed in own area of responsibility

        Implements a variety of communication tools and techniques for the promotion of safe work practices

        Ensures a variety of communication tools and techniques promoting work practices are employed in their area of responsibility


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: communication and training

        SCT 1.00. Hazard communication:* promotes safety through effective hazard communication

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SCT 1.03. Labeling

        Describes labeling of samples* and containers

        Adheres to procedures for labeling of samples and containers

        Implements procedures to ensure staff compliance with regulatory requirements for labeling of samples and containers

        Ensures staff compliance with regulatory requirements for labeling of samples and containers

        SCT 1.04. Signals and alarms

        Recognizes signals and alarms in areas assigned

        Explains signals and alarms in the laboratory facility

        Assesses staff knowledge of signals and alarms

        Ensures the implementation of all signals and alarms

        SCT 2.00. Safety training: ensures that safety training needs are identified and training solutions are implemented to meet performance and productivity goals

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SCT 2.01. Safety training

        Complies with requirements to obtain safety training

        Provides training on the work practices and techniques required for staff to safely perform their job duties

        Assesses safety training needs and the impact of safety training

        Ensures development and implementation of safety training for all staff

        SCT 2.02. Training documentation

        Describes requirements for documenting safety training

        Adheres to procedures for recording safety training of staff

        Implements procedures for documenting staff safety training

        Develops policies, processes, and procedures for documentation and verification of staff training records*

        Safety subdomain: documents and records

        SDR 1.00. Documents and record keeping: ensures staff compliance with agency quality management system (QMS)* and statutory, regulatory, accreditation,* and licensing* requirements for documentation and recordkeeping in relation to the health and safety management systems

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SDR 1.01. Safety document management

        Describes procedures for safety document management

        Adheres to procedures for safety document management

        Manages safety document management process

        Designs the safety document management system

        SDR 1.02. Safety document access

        Identifies any restricted or confidential safety documents

        Ensures restricted or confidential safety documents are not disclosed

        Implements processes and procedures for maintaining confidentiality* of internally and externally derived safety information

        Designs policies, processes, and procedures for document control and access that adhere to regulatory and accreditation requirements

        SDR 1.03. Occupational injuries and illnesses documentation

        Describes responsibilities for documenting Occupational Safety and Health Administration (OSHA)* recordable occupational injuries and illnesses

        Complies with documentation procedures for OSHA-recordable occupational injuries and illnesses

        Ensures staff compliance with reporting of OSHA-recordable occupational injuries and illnesses

        Designs policies, processes, and procedures to ensure reporting for OSHA-recordable occupational injuries and illnesses

        SDR 1.04. Medical surveillance documentation

        Describes responsibilities in complying with established medical surveillance recordkeeping procedures

        Complies with established medical surveillance documentation and recordkeeping procedures

        Implements processes and procedures for medical surveillance documentation

        Designs policies, processes, and procedures for medical surveillance documentation


        TABLE 9. (Continued) Public health laboratory competency guidelines: Safety domain

        Safety subdomain: documents and records

        SDR 1.00. Documents and record keeping: ensures staff compliance with agency quality management system (QMS)* and statutory, regulatory, accreditation,* and licensing* requirements for documentation and recordkeeping in relation to the health and safety management systems

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SDR 1.05. Exposure monitoring documentation

        Describes the procedures for documenting exposure monitoring

        Adheres to procedures for documenting exposure monitoring

        Implements procedures for documentation and retention of exposure monitoring information as required by regulations

        Designs policies, processes, and procedures for documentation and retention of exposure monitoring information as required by regulations

        SDR 1.06. Safety inspection documentation

        Describes safety inspection documentation

        Complies with procedures for safety inspection documentation

        Develops procedures for safety inspection documentation

        Designs policies, processes, and procedures for safety inspection documentation

        SDR 1.07. Hazardous waste documentation

        Describes procedures for documenting the handling and transport of hazardous waste

        Complies with procedures for documenting the handling and transport of hazardous waste

        Develops procedures for documenting the handling and transport of hazardous waste

        Ensures staff compliance with policies, processes, and procedures for documenting the handling and transport of hazardous waste

        SDR 1.08. Safety reports to staff members

        Reads safety reports

        Complies with recommendations and mandates of safety reports

        Ensures staff compliance to recommendations and mandates made in safety reports

        Designs policies, processes, and procedures ensuring staff compliance to recommendations and mandates made in safety reports

        * This term is defined in Appendix B.

        The evaluation of the probability and consequences of exposure to a given hazard, with the intent to reduce the risk by establishing the appropriate hazard controls to be used.


        TABLE 10. Public health laboratory competency guidelines: Surveillance domain

        SRV 1.00. Function of surveillance: recognizes the function of laboratory testing in surveillance

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 1.01. Function of laboratory surveillance

        Describes the importance of public health laboratory surveillance testing

        Explains the integration of public health laboratory testing into broader surveillance programs

        Ensures selected laboratory testing and reporting procedures* are aligned with surveillance activities and program requirements*

        Oversees the policies,* processes,* and procedures that ensure laboratory data will support public health surveillance activity and program requirements

        SRV 2.00. Notification rules and regulations: complies with national and jurisdictional rules and regulations regarding notifiable results*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 2.01. Notification

        Describes notification rules and regulations

        Reports data to laboratory management

        Manages the approval and communication of public health surveillance test results

        Contributes to determination of national, state, and local notification conditions

        SRV 3.00. Surveillance testing: performs surveillance testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 3.01. Surveillance testing systems

        Describes test sample* collection, storage, and analytical requirements

        Identifies the functional requirements of surveillance testing protocols

        Creates surveillance testing protocols that include functional requirements

        Directs development and modifications to surveillance testing systems based on jurisdictional guidance and analytical capabilities


        TABLE 10. (Continued) Public health laboratory competency guidelines: Surveillance domain

        SRV 3.00. Surveillance testing: performs surveillance testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 3.02. Surveillance testing workflow§

        Describes test sample collection, storage, and analytical method workflows

        Employs established testing workflow and test methods for the surveillance target requirements

        Customizes testing workflow policies and procedures to the surveillance target requirements

        Directs development and modifications to surveillance testing system workflows

        SRV 3.03. Surveillance testing

        Tests samples for surveillance

        Participates in performance evaluation of surveillance test methods and testing capabilities

        Applies technical knowledge to develop test methods and testing capabilities used in surveillance

        Oversees the selection and creation of public health surveillance tests

        SRV 3.04. Outbreak* or exposure event* detection

        Describes at least one definition of an outbreak or exposure event

        Informs supervisor of potential outbreak or exposure event

        Reports potential outbreak or exposure events to key stakeholders

        Contributes to the modification of outbreak or exposure event recognition processes or definitions

        SRV 3.05. Sample collection for outbreak or exposure events

        Receives outbreak or exposure event samples for testing

        Ensures that outbreak or exposure event samples meet sample collection criteria

        Collaborates with key stakeholders to determine the best samples to collect

        Contributes to sample collection guidelines for outbreak or exposure event scenarios

        SRV 3.06. Testing for outbreak or exposure events

        Follows sample prioritization schema for testing during an outbreak or exposure event

        Ensures that outbreak or exposure event samples are prioritized according to schema

        Reports outbreak or exposure event testing results to key stakeholders

        Represents the laboratory in After Action Reviews* for outbreak or exposure events

        SRV 4.00. Response to critical surveillance event:* responds to critical surveillance events

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 4.01. Critical event planning

        Describes critical event response processes and procedures related to surveillance

        Applies critical event processes and procedures related to surveillance

        Evaluates plans and After Action Review findings following critical events

        Modifies the policies, processes, and procedures for critical surveillance events based on results of exercises or actual events

        SRV 4.02. Critical event response

        Describes own critical event response duties related to surveillance

        Manages resources required to respond to critical events

        Implements the critical event response plan

        Oversees the activation and termination of the critical event response plan

        SRV 4.03. Coordination of response

        Describes the need to coordinate testing priorities

        Communicates testing priorities to staff and laboratory management

        Coordinates testing activities during critical events to align with identified testing priorities

        Ensures implementation of response plans during critical events

        SRV 4.04. New testing capabilities

        Identifies when current testing capabilities do not exist to test an analyte or organism

        Applies technical knowledge to implement new testing capabilities

        Develops plans to address testing capabilities for a specific new organism or analyte during critical surveillance events

        Determines the overall strategy for development of new testing capabilities during critical surveillance events


        TABLE 10. (Continued) Public health laboratory competency guidelines: Surveillance domain

        SRV 5.00. Information for surveillance: recognizes vital information needed for surveillance

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 5.01. Demographic information

        Enters demographic information that is necessary to carry out surveillance testing activities

        Communicates the required demographic information to submitters

        Ensures submission of crucial demographic information by submitters

        Determines demographic information fields required in informatics systems, requisition forms, and reports

        SRV 5.02. Sample information

        Enters sample information that is necessary to carry out surveillance testing activities

        Monitors the capture of sample information

        Ensures collection of sample information

        Determines policies, processes, and procedures for sample information collection based on jurisdictional requirements and guidelines

        SRV 6.00. Data analysis: analyzes data from surveillance testing systems

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 6.01. Data analysis

        Describes surveillance data analysis methods

        Analyses laboratory surveillance data

        Interprets laboratory surveillance data

        Develops standards for data analysis and for interpretation of laboratory surveillance data

        SRV 7.00. Data management: manages public health surveillance data using secure data management systems

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 7.01. Data collection

        Conducts data entry

        Determines validity and reliability of data collection instruments and methods

        Ensures data collection system adheres to laboratory, local, and national standards

        Coordinates modifications to data collection systems using state and national guidance and methods

        SRV 7.02. Data storage and retrieval

        Uses secure and stable data storage and retrieval systems

        Ensures that the design of storage and retrieval databases include the necessary variables and data dictionary

        Develops secure and stable data storage and retrieval systems, including creating new variables as necessary to support analysis of data

        Develops standards for secure and stable data storage and retrieval

        SRV 8.00. Recognition of significant results: recognizes significant results in surveillance data

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 8.01. Significant values and results

        Adheres to policies and procedures to verify significant results

        Reports significant results with interpretation to laboratory management and customers*

        Monitors significant results to ensure staff compliance with policies for reporting

        Develops plans with customers to identify significant results in the population or environment

        SRV 8.02. Trends in data

        Provides trend results to laboratory management

        Identifies trends in surveillance data

        Explains trends in surveillance data to laboratory management and customers

        Evaluates testing capabilities based on trend data to address customer needs and public health issues


        TABLE 10. (Continued) Public health laboratory competency guidelines: Surveillance domain

        SRV 9.00. Partnerships: maintains partnerships to conduct surveillance

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 9.01. Multidisciplinary teamwork

        Communicates approved laboratory information to other institutions

        Implements the multi-disciplinary surveillance communication plan

        Manages the multi-disciplinary surveillance communication plan

        Develops a multi-disciplinary surveillance communication plan

        SRV 9.02. Education and feedback for partners

        Explains sample requirements and testing procedures

        Guides partners in selection of laboratory methods, data collection, and evaluation

        Evaluates effectiveness and efficiency of surveillance processes and procedures between laboratory and partners

        Develops surveillance policies, processes, and procedures with partners

        SRV 10.00. Dissemination of data: disseminates data relevant to audience

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        SRV 10.01. Presentation of surveillance and monitoring data

        Describes importance and use of oral and written communication in presenting surveillance and monitoring data

        Reports surveillance and monitoring data orally or in writing to laboratory management and epidemiologists

        Explains surveillance and monitoring data orally or in writing to external stakeholders

        Synthesizes surveillance and monitoring data orally and in writing for national and international audiences for policy decision-making purposes

        * This term is defined in Appendix B.

        A detailed plan for conducting a scientific procedure.

        § Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured in the report of results, including pre-examination, examination, and postexamination procedures.


        TABLE 11. Public health laboratory competency guidelines: Informatics domain

        INF 1.00. Laboratory test request and sample* receiving: manages sample receiving and the processing of laboratory test requests

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 1.01. Sample receiving and accessioning

        Describes electronic modules* used to log in samples with corresponding electronic requests

        Verifies electronic accessioning activities to ensure completeness and accuracy

        Evaluates the electronic modules needed for sample receiving and accessioning

        Designs log-in screens to automate sample receiving and accessioning and to automate processing of electronic test request messages

        INF 1.02. Electronic data exchange regarding test requests

        Describes electronic modules used to receive data on samples using one or more standard message types*

        Performs oversight of entered data to ensure accurate mapping of client data to comparable fields in electronic systems

        Manages daily electronic data exchange activities regarding test requests to ensure efficient operations and resolution of root causes of errors

        Designs systems to automate electronic test orders and work processes*

        INF 1.03. Vocabulary standards*

        Lists local codes and standardized codes

        Manages use of vocabulary standards across parties

        Evaluates use of vocabulary standards for identification of missing or misidentified codes

        Develops codes for generation of messages using multiple standardized vocabulary formats and integration of local and new codes and vocabulary standards

        INF 1.04. Test orders

        Describes processes and procedures* for test orders

        Verifies the electronic assignment of tests to specific laboratory programs*

        Evaluates the need for new test orders and associated meta data

        Designs workflows and modules to automate assignment of test orders to specific laboratory programs

        INF 1.05. Hardware to promote sample handling efficiency

        Uses basic hardware, scanners, and robotics

        Troubleshoots installation and operation of basic automation hardware

        Configures a variety of complex hardware to ensure proper operation

        Integrates use of new technologies for sample accessioning


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 1.00. Laboratory test request and sample* receiving: manages sample receiving and the processing of laboratory test requests

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 1.06. Capture of auxiliary data

        Describes required identifiers and core data elements

        Verifies the routine entry of metadata and pass-through auxiliary data

        Manages problem resolution concerning entry of metadata and auxiliary data

        Designs modules to automate the entry of auxiliary data, the identification of core data elements, and the inclusion of new data elements

        INF 2.00. Test preparation, Laboratory Information Management System (LIMS)* processing, test results recording and verification: manages systems for electronic test preparation, LIMS processing, and test results recording and verification

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 2.01. Test preparation and receipt of samples

        Describes use of predefined electronic modules to assign samples or batches* of samples to processes in the laboratory

        Verifies the assignment of samples to individual test processes or test processing combinations

        Manages prioritization for preparation and handling of samples

        Designs systems to automate the electronic management of pre-examination* operations on samples received individually or in batch

        INF 2.02. Electronic test requests from submitters

        Describes how to use electronic modules to manage individual or batches of samples from submitters

        Verifies the receipt of samples and associated electronic test requests from submitters

        Ensures that valid values and test codes are properly harmonized between submitters and receiving laboratory

        Designs systems to automate the electronic management of test requests from submitters

        INF 2.03. LIMS tracking of testing processes and associated sample sources

        Describes how to use electronic modules to track testing processes and associated sample sources

        Verifies effectiveness of ongoing sample source tracking and submitter's monitoring efforts

        Evaluates the LIMS tracking of testing processes and associated sample sources

        Designs systems to automate and manage the tracking of testing processes and associated sample sources

        INF 2.04. Test results recording

        Describes electronic modules, vocabulary, and usage for specific test results

        Populates test results data using pre-existing modules

        Troubleshoots automated test results data capture utilities

        Designs analytical sequences for instrument integration and data capture utilities to automate data transfer from instruments

        INF 2.05. Data review

        Describes preparation of data summaries that are used for review processes

        Verifies data and results using predefined progress reports

        Evaluates the need for new tracking reports to facilitate data review

        Develops workflows and utilities to ensure that needed data are supplied

        INF 2.06. Data verification

        Explains test result choices that exist for specific test requests

        Verifies that the electronic transfer of quality assurance (QA)* and quality control (QC)* data* occurs to ensure that test results meet procedural requirements* and auto-assignment

        Institutes rules to ensure that laboratory programs have tools to manage data verification processes

        Designs the processes for automating data verification and associating QA and QC data with individual sample tests and batches before reporting

        INF 2.07. Auto-assignment of reflex* or repeat testing

        Describes the electronic processes that define auto-assignment of reflex or repeat testing

        Verifies that auto-assignment of reflex or repeat testing is performed

        Evaluates the processes for auto-assignment of reflex or repeat testing

        Develops code for design and configuration of processes for automating the assignment of reflex or repeat testing


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 3.00. Report preparation and distribution: manages test result report creation and distribution

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 3.01. Processing of data for reports

        Describes electronic modules used to print data and information* in automated reports

        Verifies analytical data, information, and reports

        Appraises solutions for data selection for nonroutine reports and for research purposes

        Constructs queries for ad hoc data searches

        INF 3.02. Report production

        Describes use of electronic modules to generate automated and manual reports or test results

        Selects results for reporting using standardized predefined report formats

        Evaluates report production processes

        Develops code to query and report laboratory data

        INF 3.03. Electronic reporting

        Sends predefined reports via electronic reporting formats

        Reports test results using predefined electronic messages that meet agreed-upon standards

        Manages the tracking and needs assessment* of electronic reporting of data

        Develops reports that contain electronic messages for test results using agreed-upon standards and vocabulary for message creation and transport

        INF 3.04. Management of reports

        Prints predefined reports according to policies*

        Verifies that reports adhere to submitters' data exchange format requirements for electronic results submittal and reporting

        Modifies noncomplex electronic formats to meet customer* requirements

        Develops automated processes to manage reporting of results

        INF 4.00. Laboratory test scheduling: manages laboratory test scheduling

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 4.01. Scheduling documents*

        Prints existing worksheets, work lists, and test scheduling documents

        Prioritizes test scheduling to resolve conflicts and turnaround time

        Develops work lists, worksheets, and test scheduling documents

        Develops processes for integration of documents to link test orders with test results

        INF 4.02. Management of test schedules

        Enters data to remove or restore completed test requests

        Uses specific data elements associated with process improvement to manage test schedules

        Evaluates the workflow for process improvement opportunities

        Develops codes to automate the creation of test status reports and workflows

        INF 4.03. Prioritization of tests

        Logs in samples according to predefined generic priorities

        Manages test requests using laboratory-specified criteria

        Organizes specific data elements associated with process improvement indicators* to prioritize test scheduling

        Develops systems to electronically generate a real-time test schedule

        INF 5.00. Prescheduled testing: manages prescheduled testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 5.01. Prescheduling

        Describes electronic modules for receipt and processing of pre-scheduled samples and kit distribution

        Manages scheduling of single or recurring test requests

        Troubleshoots electronic systems to preschedule tests and to predict and adjust workload

        Develop automated processes to manage the receipt and processing of pre-scheduled samples, recurring test requests, and kit distribution


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 6.00. Sample tracking and chain of custody:* manages the tracking of physical samples and chain of custody

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 6.01. Tracking samples at accessioning

        Uses predefined electronic modules to enter data relevant to track all steps in the sample lifecycle*

        Assigns identifiers to samples

        Evaluates automated modules that verify system operations regarding tracking

        Develops systems to determine sample tracking and location

        INF 6.02. Chain of custody

        Uses predefined modules to track and document custody of the sample from receipt to disposal or return to submitter

        Ensures staff compliance with chain of custody policies and procedures

        Manages electronic tracking data by validating that chain of custody is complete and documented

        Develops systems to electronically automate the communication of chain of custody data tracking to users and submitters

        INF 6.03. Chain of custody data elements

        Uses predefined modules to link demographic data with data on chain of custody, sample appropriateness,* sample handling, and elements of sample analyst location, time, and defined storage parameters

        Verifies that predefined modules allow creation, tracking, and maintenance of sample and aliquot hierarchy through the LIMS throughout the laboratory

        Evaluates existing and future modules for tracking data elements

        Develops systems to integrate data elements into automated chain of custody management

        INF 6.04. Tracking samples in analytical processes

        Uses predefined modules to track samples assigned to laboratory programs during analytical processes

        Verifies the routine tracking of aliquots, instrument sequence numbers, and work lists

        Creates work lists, worksheets, and workgroups to improve the tracking of samples

        Develops modules to incorporate factors that affect automated assignment of samples to work lists and integration of sample tracking into routine laboratory functions

        INF 7.00. Media, reagents, and controls: manages the manufacturing and inventory of media, reagents, and controls electronically

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 7.01. Supplies tracking

        Applies predeveloped electronic modules to order supplies and control inventory

        Verifies the tracking, management, and maintenance of inventory

        Determines the availability and cost-effectiveness of in-house manufacturing and use of supplies

        Designs code or scripts to automate activities to track, order, and manage inventory

        INF 7.02. Inventory production

        Performs data entry into existing electronic modules to document production of inventory

        Validates the production of inventory

        Evaluates data to improve the current and future states of inventory production

        Writes code or scripts to automate inventory control

        INF 7.03. Manufacturing formulations

        Accesses manufacturing formulations electronically

        Maintains the database of manufacturing formulations

        Validates manufacturing formulations and SOPs

        Develops workflows for manufacturing formulations

        INF 7.04. Supply orders and vendors

        Enters inventory order data into electronic order systems

        Verifies the use of codes and parameters necessary to automate electronic orders of supplies

        Manages order frequency and timetables

        Develops workflows to automate the ordering of supplies from vendors


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 8.00. Data exchange and interoperability: manages the electronic exchange of laboratory data with data partners

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 8.01. Laboratory data collection

        Explains data elements and formats necessary for data collection and exchange

        Identifies analytical data and results and the exchange of this information using predefined modules

        Develops automated interfaces to export data from instruments to electronic storage

        Configures modules to automate the export of analytical data to electronic storage

        INF 8.02. Electronic messaging

        Describes use of predefined modules to deliver predefined messages to partners

        Performs predefined queries of analytical data for electronic messaging

        Develops ad hoc queries for electronic messaging

        Maps electronic data to form messages consistent with client message structure, format, and vocabulary for export

        INF 8.03. Electronic messaging transport

        Describes predefined electronic messaging transport protocols§

        Sends automated electronic results to partners according to established electronic messaging transport protocols

        Determines secure electronic messaging transport protocols

        Ensures the use of secure electronic messaging transport protocols

        INF 8.04. Message vocabulary

        Describes vocabulary necessary for data exchange

        Verifies local codes are pre-mapped to nationally accepted standard codes for test requests and test results

        Evaluates processes that automate the linking of local and national codes

        Automates the mapping of test codes and results to all standardized notifiable diseases and conditions

        INF 8.05. Test order creation

        Describes standard test order vocabulary

        Communicates test orders with partners using predefined modules

        Manages the automation of test orders in collaboration with partners

        Develops protocols for automated electronic test order creation

        INF 8.06. Test order receipt and notification

        Describes standard test order receipt and notification vocabulary

        Processes test orders received from partners using predefined modules

        Manages the automation of test order receipts and notification in collaboration with partners

        Develops protocols for electronic test order receipts and notification

        INF 8.07. Test results reporting

        Describes standard test results vocabulary

        Communicates test results with partners using predefined modules

        Manages the automation of test results reporting in collaboration with partners

        Develops protocols for electronic test order results reporting

        INF 8.08. Test results acknowledgment

        Describes test results receipt acknowledgment

        Verifies test results receipt with partners using predefined modules

        Manages the automation of test results receipts in collaboration with partners

        Develops protocols for electronic test results receipts

        INF 8.09. Exchange networks

        Describes exchange networks

        Performs routine data exchange using predefined modules

        Troubleshoots exchange network interfacing

        Manages the workflow and operation of exchange networks according to information exchange standards


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 9.00. Statistical analysis and surveillance: generates statistical analyses of analytical results for public health surveillance

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 9.01. Meta data and demographic data

        Enters meta data and demographic data associated with laboratory testing

        Verifies the collection and editing of meta data and demographic data using predefined modules

        Ensures the ability to capture, retrieve, and link meta data and demographic data associated with laboratory testing

        Develops modules and workflows to electronically capture, retrieve, and link meta data and demographic data associated with laboratory testing

        INF 9.02. Statistical analysis

        Explains how automated statistical evaluation tools link meta data and demographic data within reports

        Performs predefined queries on collected data for predefined statistical analyses to link meta data and demographic data within reports

        Develops ad hoc queries to collect extracts of data for unique statistical analyses to link meta data and demographic data within reports

        Writes code or procedure code for third-party software to automate the querying and reporting of statistical data to link meta data and demographic data within reports

        INF 9.03. Laboratory performance analyses

        Describes the production of laboratory performance reports

        Provides reporting and evaluation of laboratory program performance data using predefined reports

        Develops ad hoc statistical analyses to evaluate key performance indicators

        Develops workflows and automation tools to ensure the implementation of laboratory performance-based analyses

        INF 9.04. Spatial data

        Describes modules for entering geographic information system (GIS) data

        Uses predefined tools to integrate GIS data with laboratory testing results and with meta and demographic data

        Evaluates the availability of validated tools to integrate GIS data with laboratory testing results and with meta and demographic data

        Develops modules for LIMS-associated or third-party software to integrate GIS data with laboratory testing results and with meta and demographic data

        INF 10.00. Billing for laboratory services: manages billing for laboratory services

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 10.01. Billing data

        Links existing billing code(s) with associated laboratory services at time of accessioning

        Troubleshoots billing data associated with laboratory services

        Evaluates the automated capability to link billing data with laboratory services

        Develops workflows and modules to manage the collection of financial data

        INF 10.02. Accounts receivable*

        Enters billing data in an accounts receivable program

        Performs advanced functions of automated electronic billing and linking of laboratory services to accounts receivable systems

        Manages accounts receivable systems regarding billing of services rendered

        Develops workflows and modules to automate the integration of billing information with accounts receivable software and financial services

        INF 10.03. Cost of testing and other laboratory services

        Identifies accounting codes assigned for laboratory services rendered

        Verifies that correct accounting codes are consistent with the cost of services and are linked to laboratory services rendered

        Manages accounts for cost of laboratory services to individual customers

        Develops workflows and modules to track the cost of laboratory services with customers and to manage the accounts receivable system


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 10.00. Billing for laboratory services: manages billing for laboratory services

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 10.04. Integration of laboratory billing with enterprisewide billing

        Describes billing functions for multiple systems that handle billing of laboratory services

        Verifies that accounting of laboratory services is being collected from disparate systems

        Evaluates centralized functionality regarding an enterprise-wide capability to account for costs

        Develops workflows and systems to consolidate cross-enterprise billing and accounting for laboratory services

        INF 10.05. Budgeting*

        Describes billing modules

        Performs routine reporting of billing and revenue data for fiscal analyses

        Generates detailed budgetary summaries of billing data

        Develops systems to link billing data for budgeting and trend analysis

        INF 11.00. Contract* and grant* management: manages grants and contractual instruments*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 11.01. Document management systems

        Describes centralized electronic document management systems that track and store grants, contractual instruments, and project management* materials

        Verifies the entry and timeliness of laboratory program deliverables into document management systems

        Evaluates document management systems to recommend improvements and efficiency and to meet contractual and grant obligations

        Develops enterprise-wide workflows and communications to ensure an automated and secure document management system for grants and contractual instruments

        INF 11.02. Contractual instruments

        Describes informatics support available to laboratory through contractual instruments

        Verifies the use of existing contractual instruments

        Manages contractual instruments

        Creates contractual instruments with partners to ensure informatics and information technology (IT) needs are captured

        INF 11.03. Activity tracking

        Describes informatics contractual and grant deliverables

        Tracks activities and deliverables of grants and contractual instruments using predefined electronic modules

        Evaluates the laboratory's ability to track delivery of individual informatics components related to budgetary, personnel, legal, and laboratory procedures and processes

        Develops systems to define, organize, monitor, and track the activities of grants and contractual instruments with outside parties using electronic processes

        INF 11.04. Enterprise-wide systems

        Describes contractual informatics instruments relevant to the enterprise

        Explains contractual instruments developed for individual laboratory programs for enterprise management

        Evaluates informatics contractual instruments with outside parties using electronic documentation processes

        Develops an enterprise-wide approach to information systems implementation

        INF 12.00. Training, education, and resource management: manages training, education, and information resources

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 12.01. Electronic master record*

        Accesses electronic information on staff training, education, and capabilities

        Verifies that electronic documentation of training, education, and management of educational resources is up-to-date

        Evaluates that electronic documentation of training, education, and related information meets operational requirements

        Develops modules to ensure electronic content, access, and security exist to meet the educational needs of the laboratory

        INF 12.02. Resource summaries

        Lists available electronic reports that summarize laboratory resources, including staff

        Verifies that electronic reports regarding laboratory resources are accurate and complete

        Evaluates the need for additional and revised reports on laboratory resources

        Develops modules to ensure electronic summary reports of laboratory resources are available


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 12.00. Training, education, and resource management: manages training, education, and information resources

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 12.03. Workforce development

        Describes informatics systems for tracking documented staff needs and knowledge gained from training opportunities

        Verifies that informatics processes remain up-to-date and demonstrate the acquired informatics capabilities of staff

        Evaluates laboratory informatics needs to ensure the existence of resources and avenues to support staff education and training

        Develops informatics programs to ensure that staff education and training is aligned with the business needs and directions for laboratory services and the professional growth of staff

        INF 12.04. Training activities for external partners

        Describes existing electronic documentation on trainings offered to external partners

        Verifies electronic documentation on training activities for external partners are accurate and complete

        Evaluates electronic training activities for external partners to ensure they meet current and future requirements

        Develops electronic training materials and associated documentation for external partners

        INF 12.05. Knowledge management (KM)*

        Describes own role(s) in supporting the collective knowledge within a laboratory program

        Verifies the participation and integration of program staff to ensure electronic KM within the organization

        Evaluates the effectiveness of electronic KM practices organizationally

        Develops a strategy for the creation, collection, and management of KM performance measures electronically

        INF 12.06. Lifecycle management strategy* for IT investments

        Describes laboratory IT project management resources

        Ensures the use of IT project management resources

        Evaluates staff compliance with a comprehensive lifecycle management strategy for IT investments

        Develops a comprehensive laboratory IT lifecycle management strategy

        INF 12.07. Informatics communication strategy

        Describes the strategy for communicating with internal and external partners regarding informatics capabilities and resourcing priorities

        Ensures the implementation of the communication strategy

        Evaluates staff compliance with the communication strategy

        Develops a strategy for communication of informatics capabilities and resourcing priorities to internal and external partners

        INF 13.00. Laboratory certifications,* accreditations,* and licensing:* ensures adherence to local, state, and federal certification, accreditation, and licensing requirements

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 13.01. Certification, accreditation, and licensing (CAL) compliance

        Explains applicable CAL electronic data requirements related to work area

        Verifies the implementation of predefined data processing standards and form management associated with CAL for a laboratory program

        Evaluates electronic data processing standards in order to ensure laboratory adherence to current and new CAL requirements

        Develops workflows and modules to automate laboratory adherence to data processing standards associated with CAL

        INF 13.02. External certification

        Enters data into predefined modules

        Verifies performance of predefined electronic systems regarding external certifications

        Evaluates current capabilities to manage external certifications and future needs

        Develops electronic modules to automate the management of external certifications

        INF 13.03. Privacy and security

        Describes electronic standards for own job classification related to the privacy and security of protected information*

        Ensures that individual laboratory programs adhere to electronic security and privacy standards

        Evaluates individual electronic security and privacy standards that the laboratory must meet

        Develops workflows and modules to ensure electronic systems meet security and privacy standards and adhere to regulatory requirements


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 14.00. Customer relationship management: manages customer relationships

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        14.01. Tracking customer and staff feedback

        Describes predefined modules to record customer and staff feedback

        Verifies the implementation of predefined modules to record customer and staff feedback

        Evaluates current and future needs to handle customer relationships and perform ad hoc queries to improve regulatory compliance and business management

        Develops workflow and modules that automate the collection of data to track and to perform ad hoc queries and reporting of customer and staff feedback

        INF 14.02. Tracking laboratory errors and information requests

        Describes predefined modules to record laboratory errors and information requests

        Verifies the implementation of predefined modules to record laboratory errors and information requests

        Evaluates current and future needs to track and perform ad hoc queries on laboratory errors and information requests

        Develops workflow and modules that automate the collection of data to track and to perform ad hoc queries and reporting of laboratory errors and information requests

        INF 14.03. Tracking corrective actions and reports

        Describes predefined modules that summarize reporting and corrective actions

        Verifies the implementation of predefined modules to summarize corrective actions and generate reports

        Evaluates current and future needs to track, perform ad hoc queries, and provide reports regarding corrective actions

        Develops workflow and modules that automate the collection of data to track and to perform ad hoc queries and reporting of correction actions

        INF 15.00. QC and QA management: manages quality control and quality assurance processes

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 15.01. QC data associated with sample results

        Describes predefined modules that collect QC data associated with sample results

        Verifies the electronic set-up, extraction, and transmission of QC data using predefined modules and data capture utilities for automated instruments

        Evaluates automated systems for QC data set up, extraction, and transmission

        Develops automated processes for QC data set up, extraction, and transmission

        INF 15.02. Data review and validation

        Lists QC data that are collected electronically to support validation of test results

        Performs review and validation of data

        Validates final data prior to release to customers using configurable rules-based functionality

        Develops workflows and modules to assist in automating the validation of test results

        INF 15.03. Data trending

        Enters QC data to support tracking, trending, and analysis of method accuracy and precision

        Verifies the use of automated software to support analysis of QC data related to tracking, trending, and analysis of method accuracy and precision

        Evaluates automated tracking, trending, and analysis of method accuracy and precision

        Develops the workflows and automation processes to support automated tracking, trending, and analysis of method accuracy and precision

        INF 15.04. QC reporting

        Uses predefined modules to produce electronic and paper results that include QC data associated with test runs

        Verifies the reporting and evaluation of QC data associated with analytical testing using predefined modules

        Evaluates automated reporting of QC data associated with analytical batches

        Develops reports that meet method requirements and customer needs to capture and deliver QC data in multiple formats and messages


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 15.00. QC and QA management: manages quality control and quality assurance processes

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 15.05. QA and quality management systems (QMS)*

        Describes organizational structure, policies, processes, procedures, and resources that address QA related to informatics activities

        Performs day-to-day oversight of organizational structure, policies, processes, procedures, and resources that address QA- and QMS-related to informatics activities

        Evaluates organizational structure, policies, processes, procedures, and resources that address QA- and QMS-related to informatics activities

        Develops informatics workflows and the organizational structure, policies, processes, procedures, and resources to address QMS and QA related to informatics activities

        INF 15.06. Responses to QC data

        Describes data elements needed to support automated auto-alerts, qualifiers, or triggering of responses to QC data

        Verifies that data to support auto-alerts, qualifiers, or triggering of responses to QC data are associated with test results

        Validates data elements using configurable rules-based functionality to provide auto- alerts, qualifiers, or triggering of responses to QC data

        Develops automated workflows to provide auto-alerts, qualifiers, and triggering of responses to QC data

        INF 16.00. Laboratory safety and accident investigation: manages laboratory safety and accident investigations

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 16.01. Hazardous materials* management

        Describes electronic data entry and access to hazardous material locations, safety data sheets (SDS),* procedures, disposal records* current practice standards, and master records

        Verifies the central management of hazardous materials using predefined electronic modules for reporting and tracking

        Evaluates the electronic, centralized management of hazardous materials

        Develops an electronic, centralized system to manage hazardous materials

        INF 16.02. Incident* tracking

        Describes predefined modules to track incidents

        Ensures staff compliance with electronic reporting of laboratory safety activities and accident investigations

        Manages laboratory electronic safety and accident investigation processes and procedures

        Develops electronic workflows, processes, and procedures to track and manage safety and accident investigations

        INF 16.03. Select agent* management

        Describes predefined modules related to the federal Select Agent Program* and registry

        Ensures staff compliance with regulations associated with the federal Select Agent Program and registry

        Evaluates automated processes to adhere to the federal Select Agent Program and registry

        Develops electronic modules that adhere to the federal Select Agent Program and registry

        INF 16.04. Hazardous material alerts*

        Describes system alerts associated with hazardous materials

        Verifies the generation of package and sample labels once an alert is received electronically

        Evaluates current and future electronic hazardous material alert requirements

        Develops electronic modules to manage and track activities associated with hazardous material alerts

        INF 16.05. Hazardous risk management

        Lists electronic central documents that define laboratory processes related to hazardous risk management

        Verifies that documentation systems track laboratory processes related to hazardous risk management

        Evaluates the documentation systems for laboratory processes related to hazardous risk management

        Develops task workflow analyses to ensure the electronic management of hazardous risks


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 17.00. Laboratory mutual assistance and disaster recovery: manages laboratory mutual assistance and disaster recovery

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 17.01. Continuity of Operations Plan (COOP)*

        Outlines coverage of informatics and IT services within the laboratory's COOP

        Verifies that laboratory program responsibilities are carried out during the implementation of a COOP

        Evaluates the informatics and IT aspects of the laboratory COOP to ensure they are complete and up-to-date

        Develops informatics COOP workflows and procedures to restore informatics and IT support

        INF 17.02. COOP contractual instruments

        Describes COOP formal contractual instruments involving informatics

        Verifies the performance of laboratory program informatics responsibilities pertaining to COOP contractual instruments

        Manages the documentation supporting existing informatics contractual instruments pertaining to disaster recovery and mutual assistance through drills

        Develops work plans and project management processes to ensure that comprehensive informatics contractual instruments are in place

        INF 17.03. Electronic catalogue of capacities and services

        Explains the importance of a catalogue of electronic capabilities and services, and of schedules for testing their effectiveness during disaster recovery and emergency situations

        Verifies the accuracy and access to a catalogue of electronic capabilities, services, and schedules for testing their effectiveness during disaster recovery and emergency situations

        Evaluates electronic catalogue capabilities, services, and schedules for testing their effectiveness during disaster recovery and emergency situations

        Develops workflows and project management processes to validate the electronic catalogue of capabilities, services, schedules, and testing of effectiveness during disaster recovery and emergency situations

        INF 18.00. Core IT products and services: manages core IT hardware, software, and services

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 18.01. Client-side systems and software

        Employs client-side computer systems including LIMS access protocols and routine office software

        Verifies the correct use of LIMS and advanced use of office software

        Evaluates modifications, upgrades, and new releases to laboratory instrument software and systems

        Evaluates client-side options regarding LIMS installation, management, and use

        INF 18.02. Electronic communication

        Describes communication tools for electronic information

        Determines content for electronic information communication tools

        Evaluates the use and requirements of electronic information communication tools

        Develops the technology to support electronic information communication tools

        INF 18.03. Enterprise-wide LIMS availability

        Describes LIMS management processes

        Verifies LIMS processes for data collection, data processing and reporting for laboratory business needs

        Evaluates LIMS functionality to meet laboratory and customer needs

        Manages the continuous availability and development of an enterprise-wide LIMS to ensure a fully functional and mature system

        INF 18.04. Networking

        Describes network access protocols and use of the laboratory network

        Verifies laboratory use of predefined network protocols

        Evaluates the use of networks to support laboratory activities

        Manages the administration of network servers

        INF 18.05. IT help desk

        Describes access to available IT support

        Documents the delivery of support to laboratory programs

        Evaluates IT support needed for laboratory operations

        Develops formal contractual instruments, workflows, and project management processes for the delivery of IT support throughout the laboratory


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 18.00. Core IT products and services: manages core IT hardware, software, and services

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 18.06. Software development life cycle (SDLC)*

        Describes the processes to use and improve electronic laboratory workflows and algorithms

        Verifies needs for software process improvements

        Evaluates the resources that impact the SDLC

        Manages the SDLC at the enterprise-level, including change management*

        INF 18.07. Enterprise integration engine*

        Lists predefined functions that use an integration engine

        Verifies the use of predefined integration engine modules

        Evaluates integration functions with partners and customers

        Develops automated workflows and processes regarding data capture and use of an integration engine to message data

        INF 18.08. Legacy data systems*

        Defines legacy data systems

        Verifies access to, and use of, legacy data systems

        Evaluates the accessibility and searchability of legacy data

        Develops workflows and processes to ensure that legacy data are accessible and searchable

        INF 18.09. LIMS communication with third-party data systems

        Describes predefined modules to support LIMS communication with third-party data systems

        Verifies the proper use of predefined modules to support LIMS communication with third-party data systems

        Evaluates the ability of the LIMS to communicate with third-party data systems

        Develops workflows and processes to support LIMS communications with third-party systems

        INF 18.10. Access and audit trails

        Describes modules that provide a view of audit trails

        Verifies staff access to electronic audit trails

        Evaluates the ability of the LIMS to manage access and audit trails

        Develops protocols to manage access and audit trails

        INF 18.11. Instrument analysis software

        Describes instrument analysis software systems

        Uses instrument analysis software

        Evaluates analytical instrument software

        Develops analytical instrument software systems

        INF 18.12. Computer maintenance and troubleshooting

        Identifies basic computer problems

        Performs routine computer maintenance and troubleshooting

        Performs complex computer maintenance and troubleshooting

        Manages the computer maintenance and troubleshooting processes

        INF 19.00. Policies and procedures: manages operational, budgeting and funding policies and procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 19.01. Informatics policy

        Describes existing informatics policies

        Ensures laboratory program adherence to existing informatics policies

        Evaluates informatics policies

        Develops processes for informatics policy making

        INF 19.02. Change control

        Describes change control processes related to informatics

        Ensures laboratory program adherence to the change control processes related to informatics

        Evaluates the effectiveness of change control processes related to informatics

        Develops informatics policies, processes, and procedures to manage change control and ensure staff compliance

        INF 19.03. Documentation for standardized laboratory IT processes

        Provides documentation for standardized laboratory IT processes

        Verifies that paper and electronic documentation of laboratory IT processes are centrally located and accessible

        Evaluates completeness of documentation for standardized laboratory IT processes

        Develops workflows and processes to ensure paper and electronic documentation is centrally located and accessible

        INF 19.04. Operational budgeting strategy

        Describes the importance of electronic budgetary processes

        Identifies informatics business needs of the laboratory program for operational budgeting strategizing

        Evaluates the operational budgeting strategy

        Develops a budgeting strategy for the laboratory's informatics systems and services


        TABLE 11. (Continued) Public health laboratory competency guidelines: Informatics domain

        INF 19.00. Policies and procedures: manages operational, budgeting and funding policies and procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        INF 19.05. Capital budgeting*

        Describes the capital budgeting processes for informatics-related assets*

        Provides the listing of capital budget needs regarding laboratory informatics

        Evaluates capital budgeting needs regarding laboratory informatics

        Develops capital budgets for electronic information systems and services

        INF 19.06. Partnership channels

        Lists established stakeholders and partnership channels

        Presents short- and long-term informatics business needs to management staff

        Ensures that laboratory informatics business needs are presented to stakeholders and partnership channels

        Develops partnerships to facilitate funding for informatics

        * This term is defined in Appendix B.

        All of the tasks, in the proper order, required to carry out a process.

        § A set of technical rules for the transmission and receipt of information between computers.

        A process for implementing changes to software or other information technology solutions using a coordinated approach.


        TABLE 12. Public health laboratory competency guidelines: Microbiology domain

        MCB 1.00. Concepts and techniques: adheres to policies* and principles governing actions and behaviors that are essential when working in a microbiology laboratory

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 1.01. Microbiological concepts and theories*

        Describes basic microbiological concepts and theories

        Relates microbiological concepts and theories to the specific tests that are conducted

        Ensures microbiological concepts and theories are applied in laboratory testing

        Evaluates laboratory practices for adherence to accepted microbiological concepts and theories

        MCB 1.02. Basic microbiological techniques

        Applies basic microbiological techniques to laboratory testing

        Integrates basic microbiological techniques into new laboratory practices and procedures*

        Trains staff on basic microbiological techniques

        Ensures implementation of basic microbiological techniques into laboratory practices

        MCB 2.00. Facilities and safety: works safely with microbiological agents within a laboratory facility*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 2.01. Laboratory hazards related to microbiological agents

        Recognizes laboratory hazards and hazard communication* related to microbiological agents

        Instructs others on laboratory hazards and hazard communication related to microbiological agents

        Ensures staff compliance with policies, processes,* and procedures addressing laboratory hazards related to microbiological agents

        Develops policies, processes, and procedures regarding hazards related to microbial agents based on risk assessments

        MCB 2.02. Safe work practices*

        Adheres to policies, processes, and procedures regarding safe work practices related to microbiological agents

        Instructs others in policies, processes, and procedures regarding safe work practices related to microbiological agents

        Ensures staff compliance with policies, processes, and procedures regarding safe work practices related to microbiological agents

        Creates a culture of biosafety by ensuring that policies, processes, and procedures regarding safe work practices related to microbiological agents are aligned with current standards and regulatory requirements


        TABLE 12. (Continued) Public health laboratory competency guidelines: Microbiology domain

        MCB 2.00. Facilities and safety: works safely with microbiological agents within a laboratory facility*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 2.03. Personal protective equipment (PPE)*

        Adheres to policies, processes, and procedures regarding PPE use for work related to microbiological agents

        Instructs staff in policies, processes, and procedures regarding PPE use for work related to microbiological agents

        Ensures staff compliance with policies, processes, and procedures regarding PPE use for work related to microbiological agents

        Establishes policies, processes, and procedures regarding PPE use for work related to microbiological agents

        MCB 2.04. Biosafety cabinets and other engineering controls*

        Adheres to policies, processes, and procedures regarding the use of biosafety cabinets and other engineering controls

        Instructs staff in use of biosafety cabinets and other engineering controls

        Ensures laboratory adherence to biosafety cabinet certification* and staff compliance with policies, processes, and procedures regarding the use of biosafety cabinets and other engineering controls

        Establishes policies, processes, and procedures, including training, to ensure implementation and use of biosafety cabinets and other engineering controls

        MCB 2.05. Waste management related to microbiological agents

        Adheres to policies, processes, and procedures regarding waste management related to microbiological agents

        Instructs staff in waste management policies, processes, and procedures related to microbiological agents

        Establishes waste management processes and procedures related to microbiological agents

        Oversees the waste management plan* related to microbiological agents

        MCB 2.06. Decontamination*

        Adheres to policies, processes, and procedures regarding decontamination

        Instructs staff in the policies, processes, and procedures regarding decontamination for different microorganisms

        Ensures staff compliance with policies, processes, and procedures regarding decontamination

        Develops policies, processes, and procedures related to decontamination

        MCB 2.07. Storage of microbiological materials

        Adheres to policies, processes, and procedures regarding storage of microbiological materials

        Instructs staff in policies, processes, and procedures regarding the storage of microbiological materials for different microorganisms

        Ensures staff compliance with policies, processes, and procedures that address the storage of microbiological materials

        Develops policies, processes, and procedures related to the storage of microbiological materials

        MCB 3.00. Pre-examination:* assesses microbiological samples* during the pre-examination phase

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 3.01. Sample collection, labeling, and handling

        Describes routine sample collection, labeling, and handling policies, processes, and procedures for microbiological examination

        Consults on nonroutine sample collection, labeling, and handling procedures for microbiological examination

        Monitors staff compliance with established policies, processes, and procedures regarding microbiological sample collection, labeling, and handling

        Oversees the policies, processes, and procedures for sample collection, labeling, and handling for microbiological examination

        MCB 3.02. Packaging and shipping

        Performs packing and shipping of Category A* and Category B* infectious substances

        Instructs others on packing and shipping of Category A and Category B infectious substances

        Ensures staff compliance with policies, processes, and procedures regarding the packing and shipping of Category A and Category B infectious substances

        Develops policies, processes, and procedures to ensure staff compliance with packing and shipping regulations concerning Category A and Category B infectious substances

        MCB 3.03. Material transport

        Describes the importance of adhering to established policies, processes, and procedures regarding microbiological material transport

        Instructs others on microbiological material transport policies, processes, and procedures

        Develops microbiological material transport processes and procedures

        Oversees the policies, processes, and procedures regarding microbiological material transport


        TABLE 12. (Continued) Public health laboratory competency guidelines: Microbiology domain

        MCB 3.00. Pre-examination:* assesses microbiological samples* during the pre-examination phase

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 3.04. Biological threats

        Describes policies, processes, and procedures for the identification, handling, safety, appropriateness and triage of samples containing agents of concern

        Adheres to policies, processes, and procedures regarding the identification, handling, safety, appropriateness and triage of samples containing agents of concern

        Ensures staff compliance with policies, processes, and procedures regarding the identification, handling, safety, appropriateness and triage of samples containing agents of concern

        Oversees the policies, processes, and procedures regarding the identification, handling, safety, appropriateness and triage of samples containing agents of concern

        MCB 3.05. Accessioning and receipt

        Performs procedures for accessioning and receipt of microbiological samples

        Instructs staff in policies, processes, and procedures regarding accessioning and receipt of microbiological samples

        Develops processes and procedures for microbiological sample accessioning and receipt

        Oversees the policies, processes, and procedures regarding microbiological sample accessioning and receipt

        MCB 3.06. Sample tracking

        Performs systematic tracking of microbiological samples from receipt to final disposition

        Instructs staff on policies, processes, and procedures for the systematic tracking of microbiological samples from receipt to final disposition

        Develops processes and procedures for the systematic tracking of microbiological samples from receipt to final disposition

        Oversees the policies, processes, and procedures for the systematic tracking of microbiological samples from receipt to final disposition

        MCB 3.07. Sample evaluation and appropriateness* for testing

        Assesses sample appropriateness for a particular microbiological examination

        Instructs others in the appropriateness of routine and nonroutine samples for microbiological examination

        Develops processes and procedures for assessment of routine and nonroutine sample appropriateness for microbiological examination

        Oversees the policies, processes, and procedures regarding assessment of routine and nonroutine sample appropriateness for microbiological examination

        MCB 3.08. Testing workflow§

        Adheres to policies, processes, and procedures regarding testing workflow

        Instructs staff in policies, processes, and procedures regarding testing workflow

        Ensures staff compliance with policies, processes, and procedures related to testing workflow

        Establishes policies, processes, and procedures related to testing workflow

        MCB 3.09. Nucleic Acid Amplification Tests (NAAT) workflow (facility specific)

        Adheres to policies, processes, and procedures regarding NAAT workflow

        Instructs staff in policies, processes, and procedures regarding NAAT workflow, including pre- and postamplification areas

        Ensures staff compliance with policies, processes, and procedures regarding NAAT workflow

        Establishes policies, processes, and procedures for NAAT workflow

        MCB 3.10. Sample set-up

        Performs sample set-up procedures for microbiological examinations

        Instructs staff in sample set-up for microbiological examinations

        Develops processes and procedures regarding sample set-up for microbiological examinations

        Oversees the policies, processes, and procedures regarding sample set-up for microbiological examinations

        MCB 3.11. Sample storage and handling

        Performs procedures for microbiological sample storage and handling prior to examination

        Instructs staff in procedures for microbiological sample storage and handling prior to examination

        Develops processes and procedures for microbiological sample storage and handling prior to examination

        Oversees the policies, processes, and procedures regarding microbiological sample storage and handling prior to examination

        MCB 3.12. Epidemiologic collaboration

        Describes which microbiological examination requests require epidemiologic notification and consultation

        Reports to epidemiologists when microbiological examination requests warrant notification

        Ensures staff compliance with policies, processes, and procedures for notification and consultation with epidemiologists regarding microbiological examination requests

        Oversees the policies, processes, and procedures for notification and consultation with epidemiologists regarding microbiological examination requests


        TABLE 12. (Continued) Public health laboratory competency guidelines: Microbiology domain

        MCB 4.00. Examination:* assesses microbiological samples during the examination phase

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 4.01. Preparation of culture media

        Prepares culture media according to policies, processes, and procedures

        Instructs staff on the preparation of culture media

        Ensures staff compliance with policies, processes, and procedures regarding quality practices for media preparation

        Oversees the policies, processes, and procedures for media preparation

        MCB 4.02. Selection of media

        Selects media according to procedures

        Instructs staff in the media selection process

        Ensures staff compliance with policies, processes and procedures regarding quality practices for media selection

        Oversees the policies, processes, and procedures regarding media selection

        MCB 4.03. Culture inoculation

        Performs culture inoculation using aseptic techniques

        Instructs staff in how to inoculate cultures using aseptic technique

        Ensures staff compliance with policies, processes and procedures regarding quality practices for culture inoculation

        Oversees the policies, processes, and procedures regarding culture inoculation

        MCB 4.04. Microscopic examination with morphological characteristics

        Recognizes the morphological characteristics of different organisms

        Instructs staff in morphological identification and differentiating organisms from artifacts

        Ensures staff compliance with policies, processes and procedures regarding quality practices for morphological identification

        Oversees the policies, processes, and procedures regarding morphological identification

        MCB 4.05. Culture growth characteristics

        Recognizes growth characteristics of microorganisms

        Instructs staff in identifying growth characteristics of microorganisms

        Ensures staff compliance with policies, processes and procedures regarding quality practices for identifying microorganism growth characteristics

        Oversees the policies, processes, and procedures for interpretation of microorganism growth characteristics

        MCB 4.06. Manual identification* and susceptibility testing* methods

        Performs identification and susceptibility testing using manual methods

        Instructs staff in the performance of identification and susceptibility testing using manual methods

        Ensures staff compliance with policies, processes, and procedures regarding quality practices for performing identification and susceptibility testing using manual methods

        Oversees the policies, processes, and procedures regarding the performance of identification and susceptibility testing using manual methods

        MCB 4.07. Automated identification* and susceptibility testing* systems

        Performs identification and susceptibility testing using automated systems

        Instructs staff in the performance of identification and susceptibility testing using automated systems, including how to utilize algorithms to determine additional testing

        Ensures staff compliance with policies, processes, and procedures regarding quality practices for performing identification and susceptibility testing using automated systems

        Oversees the policies, processes, and procedures regarding the performance of identification and susceptibility testing using automated systems

        MCB 4.08. Agent-specific antigen detection*

        Performs antigen detection methods

        Instructs staff in how to perform antigen detection methods

        Ensures staff compliance with policies, processes, and procedures regarding quality practices for antigen detection methods

        Oversees the policies, processes, and procedures for antigen detection

        MCB 4.09. Nucleic acid (NA) sequencing of infectious agents

        Performs NA sequencing of infectious agents

        Instructs staff in the performance of NA sequencing for the identification of infectious agents

        Ensures staff compliance with policies, processes, and procedures regarding quality practices for NA sequencing of infectious agents, including the selection and utilization of databases

        Oversees the policies, processes, and procedures regarding NA sequencing and sequence-based identification


        TABLE 12. (Continued) Public health laboratory competency guidelines: Microbiology domain

        MCB 4.00. Examination:* assesses microbiological samples during the examination phase

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 4.10. Strain typing methods*

        Performs strain typing

        Instructs staff in how to perform strain typing

        Ensures staff compliance with policies, processes, and procedures regarding quality practices for strain typing

        Oversees the policies, processes, and procedures regarding strain typing

        MCB 4.11. Rule-out testing for agents of concern

        Explains the policies, processes, and procedures regarding rule-out testing and referral

        Performs rule-out testing and referral for identification, confirmation, and characterization of agents of concern

        Ensures the laboratory responds quickly to needs for rapid testing with timely notification and secure messaging of results

        Oversees the policies, processes, and procedures regarding rule-out testing and referral

        MCB 4.12. Quality control (QC)* analysis

        Performs QC activities

        Interprets QC data prior to reporting results

        Examines QC data over time to establish QC ranges and limits

        Ensures the QC program adheres to regulatory requirements*

        MCB 5.00. Postexamination:* performs postexamination procedures of microbiological testing

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 5.01. QC evaluation

        Assembles QC data for evaluation

        Evaluates QC data for a given data reporting period

        Ensures staff compliance with established policies, processes, and procedures for QC evaluation activities

        Oversees the policies, processes, and procedures related to QC evaluation activities

        MCB 5.02. Test analysis and results interpretation

        Assembles test data for review and action

        Analyzes test data

        Interprets complex or ambiguous results

        Oversees the policies, processes, procedures, and algorithms related to data analysis and results interpretation

        MCB 5.03. Results reporting and data release

        Adheres to policies, processes and procedures related to reporting and release of examination results and notifiable results*

        Instruct staff in the policies, processes, and procedures related to reporting and release of examination results and notifiable results

        Ensures staff compliance with policies, processes and procedures related to reporting and release of examination results and notifiable results

        Oversees the policies, processes, and procedures, related to reporting and release of examination results and notifiable results to partners

        MCB 5.04. Quality assurance (QA)*

        Explains the differences between QA and QC

        Collects data for reporting on QA indicators

        Evaluates QA indicator data

        Oversees the policies, processes, and procedures related to QA


        TABLE 12. (Continued) Public health laboratory competency guidelines: Microbiology domain

        MCB 6.00. Regulatory compliance: ensures regulatory compliance

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        MCB 6.01. Nonconforming event (NCE)* tracking

        Recognizes NCEs in laboratory processes

        Documents NCEs on discovery for implementation of corrective actions

        Analyzes NCEs for corrective actions and documentation

        Designs a management system for NCEs

        MCB 6.02. Proficiency testing (PT)* and alternative assessment*

        Performs PT and alternative assessment

        Reviews PT and alternative assessment results

        Monitors to ensure the PT and alternative assessment program meets regulatory requirements

        Oversees the policies, processes, and procedures related to PT and alternative assessments

        MCB 6.03. Method validation* and performance verification*

        Participates in performance of method validation and performance verification

        Compiles results of method validation and performance verification

        Evaluates method validation and performance verification results

        Oversees the policies, processes, and procedures related to method validation and performance verification

        MCB 6.04. Development and validation of laboratory-developed tests (LDTs)*

        Participates in the development of LDTs

        Evaluates LDT validation data

        Creates processes and procedures for the development and validation of LDTs

        Oversees the policies, processes, and procedures regarding the development and validation of LDTs

        MCB 6.05. Select agents*

        Describes the policies, processes, and procedures related to the federal Select Agent Program,* including the securing, safe handling, and testing of select agents and the documentation of activities

        Complies with policies, processes, and procedures related to the federal Select Agent Program, including the securing, safe handling, and testing of select agents and the documentation of activities

        Implements policies, processes, and procedures regarding select agent security, biosafety, testing, and incident response plans*

        Oversees select agent security, biosafety, testing, and incident response plans to ensure alignment with select agent regulations

        * This term is defined in Appendix B.

        The evaluation of the probability and consequences of exposure to a given hazard, with the intent to reduce the risk by establishing the appropriate hazard controls to be used.

        § Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured in the report of results, including pre-examination, examination, and postexamination procedures.

         


        TABLE 13. Public health laboratory competency guidelines: Chemistry domain

        CHM 1.00. Concepts and techniques: applies knowledge of chemical concepts* and techniques to studies of biological and environmental matrices

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 1.01. Chemical properties

        Applies knowledge of the properties of matter to assist in chemical analyses

        Integrates knowledge of the properties of matter into new chemical analyses

        Differentiates chemical properties to improve chemical analyses

        Integrates new understandings of chemical properties to address occupational exposures or environmental or other public health issues

        CHM 1.02. Chemical concepts

        Describes chemical concepts

        Applies chemical concepts to analyses

        Differentiates chemical concepts in analyses

        Formulates new chemical concepts to improve determinations

        CHM 1.03. Laboratory statistics

        Explains statistical concepts and practices

        Collects data for statistical analyses

        Evaluates summarized data for statistical analyses

        Oversees the development and use of statistical programs

        CHM 1.04. Equations and calculations

        Performs chemical calculations

        Instructs staff in the performance of chemical calculations

        Determines when and which chemical equations and calculations are needed

        Oversees the use and interpretation of chemical equations and calculations

        CHM 1.05. Measurements

        Performs measurements and unit conversion calculations

        Instructs staff in measurements and unit conversion calculations

        Determines the needed accuracy and precision of measurements

        Develops processes* and procedures* to maximize the accuracy and precision of measurements and techniques


        TABLE 13. (Continued) Public health laboratory competency guidelines: Chemistry domain

        CHM 2.00. Facilities and safety: works safely with hazardous materials* within a laboratory facility*

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 2.01. Chemical hazards

        Recognizes chemical hazards and chemical hazard communication*

        Instructs others on chemical hazards and hazard communication

        Implements hazard communication procedures and training

        Develops strategies to reduce chemical hazards based on risk assessments

        CHM 2.02. Safe work practices*

        Adheres to safe work practices related to chemical hazards

        Instructs others in safe work practices, policies, and procedures related to chemical hazards

        Ensures staff compliance with policies,* processes, and procedures related to safe work practices related to chemical hazards

        Creates a culture of safety by ensuring that policies, processes, and procedures regarding safe work practices related to chemical hazards are aligned with current standards and regulatory requirements

        CHM 2.03. Personal protective equipment (PPE)*

        Adheres to policies, processes, and procedures regarding PPE use

        Instructs staff in the use of PPE

        Ensures that staff are trained and comply with policies, processes, and procedures regarding the use of PPE

        Establishes policies, processes, and procedures regarding the use of PPE

        CHM 2.04. Engineering controls*

        Adheres to policies, processes, and procedures regarding the use of engineering controls

        Instructs staff in the use of engineering controls

        Ensures that staff are trained and comply with policies, processes, and procedures regarding the use of engineering controls

        Establishes policies, processes, and procedures regarding the use of engineering controls

        CHM 2.05. Waste management related to samples*

        Adheres to policies, processes, and procedures related to sample waste management

        Instructs staff in sample waste management policies, processes, and procedures

        Establishes sample waste management policies, processes, and procedures

        Oversees the sample waste management plan*

        CHM 3.00. Pre-examination:* performs chemistry pre-examination procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 3.01. Sample collection, labeling, and handling

        Describes routine sample collection, labeling, and handling policies, processes, and procedures for chemical examination

        Consults on nonroutine sample collection, labeling, and handling procedures for chemical examination

        Monitors staff compliance with established policies, processes, and procedures regarding chemical sample collection, labeling, and handling

        Oversees the policies, processes, and procedures for the collection and handling of samples for chemical examination

        CHM 3.02. Packaging and shipping

        Performs the packing and shipping of hazardous samples

        Instructs others on packing and shipping of hazardous samples

        Ensures staff compliance with policies, processes, and procedures regarding the packing and shipping of hazardous samples

        Develops policies, processes, and procedures to ensure staff compliance with packing and shipping regulations concerning hazardous samples

        CHM 3.03. Material transport

        Describes the importance of adhering to established policies, processes, and procedures regarding transport of materials for chemical examination

        Instructs others on material transport policies, processes, and procedures

        Develops material transport processes and procedures

        Oversees the policies, processes, and procedures for the transport of materials for chemical examination

        CHM 3.04. Chemical threats

        Describes the policies, processes, and procedures for the identification, handling, safety, appropriateness and triage of samples containing chemical agents of concern

        Adheres to policies, processes, and procedures regarding the identification, handling, safety, appropriateness and triage of samples containing chemical agents of concern

        Ensures staff compliance with policies, processes, and procedures regarding the identification, handling, safety, appropriateness and triage of samples containing chemical agents of concern

        Oversees the policies, processes, and procedures regarding the identification, handling, safety, appropriateness and triage of samples containing chemical agents of concern


        TABLE 13. (Continued) Public health laboratory competency guidelines: Chemistry domain

        CHM 3.00. Pre-examination:* performs chemistry pre-examination procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 3.05. Accessioning and receipt

        Performs procedures for sample accessioning and receipt

        Instructs staff on policies, processes, and procedures regarding sample accessioning and receipt

        Manages the policies, processes, and procedures for sample accessioning and receipt

        Designs policies, processes, and procedures regarding sample accessioning and receipt

        CHM 3.06. Sample tracking

        Performs systematic tracking of samples from receipt to final disposition

        Instructs staff on policies, processes, and procedures for the systematic tracking of samples from receipt to final disposition

        Manages the policies, processes, and procedures for the systematic tracking of samples from receipt to final disposition

        Designs polices, processes, and procedures for the systematic tracking of samples from receipt to final disposition

        CHM 3.07. Sample evaluation and appropriateness* for testing

        Assesses appropriateness of routine samples for chemical examination

        Instructs others in appropriateness of routine and nonroutine samples for chemical examination

        Manages the policies, processes, and procedures for assessment of routine and nonroutine sample appropriateness for chemical examination

        Establishes policies, processes, and procedures regarding the assessment of routine and nonroutine sample appropriateness for chemical examination

        CHM 3.08. Testing workflow§

        Adheres to policies, processes, and procedures regarding testing workflow

        Instructs staff in policies, processes, and procedures regarding testing workflow

        Ensures laboratory processes and procedures include use of testing workflow

        Develops policies, processes, and procedures related to testing workflow

        CHM 3.09. Sample processing

        Performs sample processing procedures for routine chemical examinations

        Performs sample processing for complex chemical examinations

        Instructs staff on sample processing for routine and complex chemical examinations

        Develops policies, processes, and procedures regarding sample processing for routine and complex chemical examinations

        CHM 3.10. Pre-examination sample storage and handling

        Performs procedures for sample storage and handling prior to examination

        Instructs staff in procedures for sample storage and handling prior to examination

        Manages processes and procedures for sample storage and handling prior to examination

        Designs policies, processes, and procedures regarding sample storage and handling prior to examination

        CHM 3.11. Epidemiologic collaboration

        Describes which chemical examination requests require epidemiologic notification and consultation

        Reports to epidemiologists when chemical examination requests warrant notification

        Manages the policies, processes, and procedures for notification and consultation with epidemiologists regarding chemical examination requests

        Designs policies, processes, and procedures regarding notification and consultation with epidemiologists regarding chemical examination requests

        CHM 4.00. Examination:* performs chemistry examination procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 4.01. Examination

        Performs chemistry examination procedures

        Instructs staff in chemistry examination procedures

        Monitors staff compliance with chemistry examination policies, processes, and procedures

        Oversees chemistry examination policies, processes, and procedures

        CHM 4.02. Chemical extractions

        Performs routine chemical extraction methods

        Performs nonroutine chemical extractions

        Selects chemical extractions for an identified purpose

        Develops new and improved types of chemical extractions

        CHM 4.03. Quality control (QC)* analysis

        Performs QC activities

        Interprets QC data prior to reporting results

        Examines QC data over time to establish QC ranges and limits

        Ensures the QC program adheres to regulatory requirements*

        CHM 4.04. Equipment troubleshooting

        Identifies basic laboratory equipment* problems

        Corrects equipment problems or failures

        Monitors equipment functioning during its lifecycle

        Develops equipment troubleshooting processes and procedures


        TABLE 13. (Continued) Public health laboratory competency guidelines: Chemistry domain

        CHM 4.00. Examination:* performs chemistry examination procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 4.05. Sample storage and handling after examination

        Performs procedures for sample storage and handling after examination

        Instructs staff in procedures for sample storage and handling after examination

        Manages processes and procedures for sample storage and handling after examination

        Designs policies, processes, and procedures for sample storage and handling after examination

        CHM 5.00. Postexamination:* performs chemistry postexamination procedures

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 5.01.QC evaluation

        Assembles QC data for evaluation

        Evaluates QC data for a given data reporting period

        Ensures staff compliance with established policies, processes, and procedures for QC evaluation activities

        Oversees the policies, processes, and procedures related to QC evaluation activities

        CHM 5.02. Test analysis and results interpretation

        Assembles test data for review and action

        Analyzes test data

        Interprets complex or ambiguous results

        Oversees the policies, processes, procedures, and algorithms related to data analysis and results interpretation

        CHM 5.03. Results reporting and data release

        Adheres to policies, processes and procedures related to reporting and release of examination results and notifiable results*

        Instruct staff in the policies, processes, and procedures related to reporting and release of examination results and notifiable results

        Ensures staff compliance with policies, processes and procedures related to reporting and release of examination results and notifiable results

        Oversees the policies, processes, and procedures, related to reporting and release of examination results and notifiable results to partners

        CHM 5.04. Quality assurance (QA)*

        Explains the differences between QA and QC

        Collects data for reporting on QA indicators

        Evaluates QA indicator data

        Oversees the policies, processes, and procedures related to QA

        CHM 6.00. Regulatory compliance: ensures regulatory compliance

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        CHM 6.01. Nonconforming event (NCE)* tracking

        Recognizes NCEs in laboratory processes

        Documents NCEs on discovery for implementation of corrective actions

        Analyzes NCEs for corrective actions and documentation

        Designs a management system for NCEs

        CHM 6.02. Proficiency testing (PT)* and alternative assessment*

        Performs PT and alternative assessment

        Reviews PT and alternative assessment results

        Monitors to ensure the PT and alternative assessment program meets regulatory requirements

        Oversees the policies, processes, and procedures related to PT and alternative assessments

        CHM 6.03. Method validation* and performance verification*

        Participates in performance of method validation and performance verification

        Compiles results of method validation and performance verification

        Evaluates method validation and performance verification results

        Oversees the policies, processes, and procedures related to method validation and performance verification

        CHM 6.04. Development and validation of laboratory-developed tests (LDTs)*

        Participates in the development of LDTs

        Evaluates LDT validation data

        Creates processes and procedures for the development and validation of LDTs

        Oversees the policies, processes, and procedures regarding the development and validation of LDTs

        * This term is defined in Appendix B.

        The evaluation of the probability and consequences of exposure to a given hazard, with the intent to reduce the risk by establishing the appropriate hazard controls to be used.

        § Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured in the report of results, including pre-examination, examination, and postexamination procedures.


        TABLE 14. Public health laboratory competency guidelines: Bioinformatics domain

        BIO 1.00. Biology and computer science knowledge: integrates knowledge of biology and computer science

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        BIO 1.01. Domain-specific biology principles

        Identifies potential biological problems to be addressed by computer science techniques

        Determines biological problems to be addressed by computer science techniques

        Evaluates the effectiveness of the selected computer science technique(s) in addressing biological problems

        Selects biological problems to be addressed by computer science techniques

        BIO 1.02. Domain-specific computer science principles

        Identifies computer science domains* to apply to biological problems

        Applies computer science domains to biological problems

        Evaluates computer science domains to apply to biological problems

        Develops new understandings of computer science domains to apply to biological problems

        BIO 2.00. Statistical methods knowledge: applies knowledge of statistical methods for analysis of biological data

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        BIO 2.01. Statistical analysis

        Prepares data for processing

        Uses simple statistical analysis to analyze trends and patterns and to draw conclusions related to the biological data

        Compares findings to any related data sets

        Oversees selection of advanced statistical methods applicable to specific bioinformatics analyses


        TABLE 14. (Continued) Public health laboratory competency guidelines: Bioinformatics domain

        BIO 3.00. Data analysis: analyzes biological data

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        BIO 3.01. Data analysis

        Selects which existing tools and algorithms to use for any given analysis

        Determines options and parameters of tools to meet specified needs of a given data analysis

        Implements new software tools to address unmet needs or improve current processes*

        Creates stand-alone analysis tools

        BIO 3.02. Data interpretation

        Identifies data pertinent to the analysis problem

        Formulates results of analyses, including information in the form of graphs, charts, and tables

        Interprets results within the context of the analysis problem

        Generates hypotheses to predict future implications based on the evaluation of data analyses

        BIO 3.03. Data visualization and representation

        Uses data visualization and representation tools to present results of data analyses

        Selects visualization and representation tools for specified bioinformatics problems

        Evaluates representation and visualization tools for summarizing data analyses

        Modifies existing visualization and representation tools to provide insight into bioinformatics analyses

        BIO 3.04. Communication

        Discusses bioinformatics with other scientists within their institution

        Initiates bioinformatics collaborations with colleagues

        Facilitates knowledge-sharing with stakeholders

        Contributes to new findings and meaningful advancements in bioinformatics through the evaluation and sharing of knowledge

        BIO 4.00. Data management: conducts data management, storage, and retrieval

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        BIO 4.01. Data structures*

        Demonstrates basic knowledge of data structures

        Applies knowledge of data structures to relevant problems

        Manipulates data structures to address biological problems

        Develops new data structures

        BIO 4.02. Data management

        Describes data management techniques

        Applies knowledge of data management techniques to relevant problems

        Evaluates data management techniques

        Develops new data management techniques

        BIO 4.03. Data storage and retrieval

        Describes data storage and retrieval techniques

        Applies knowledge of data storage and retrieval techniques

        Evaluates data storage and retrieval techniques

        Develops new data storage and retrieval techniques

        BIO 4.04. Allocation of computing resources

        Describe available computing resources and capacity

        Allocates computing resources

        Manages allocation of multiple computing resources

        Develops new methods for allocation of computing resources

        * This term is defined in Appendix B.


        TABLE 15. Public health laboratory competency guidelines: Research domain

        RES 1.00. Research programs: develops research programs

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 1.01. Research objectives and agenda

        Describes the laboratory's research objectives

        Illustrates how research projects fit within the laboratory's research objectives and agenda

        Formulates research projects that align with the laboratory's research objectives and agenda

        Develops hypothesis-driven research objectives and a research agenda for the laboratory

        RES 1.02. Research funding

        Describes general funding mechanisms that support public health research

        Participates in writing funding proposals for research projects

        Leads drafting of research funding proposals

        Manages the overall processes* for obtaining and sustaining research funds

        RES 1.03. Funding proposal reviews

        Describes basics of the proposal review process

        Reviews internal proposals to verify adherence to guidelines and recommended principles

        Serves as an ad hoc reviewer for research proposal reviews

        Serves on research proposal review committees

        RES 1.04. Research staffing needs

        Describes own role as part of the research staff

        Recognizes research staffing needs

        Participates in hiring research staff

        Develops the strategic plan to recruit and retain researchers

        RES 1.05. Research resource management

        Uses financial and material resources judiciously

        Considers available financial, human, and material resources when planning experiments

        Assesses financial, human, and material resources when planning research projects

        Aligns financial, human, and material resources to support the research program

        RES 1.06. Regulatory requirements*

        Complies with regulatory requirements in the performance of research

        Identifies noncompliance with regulatory requirements pertaining to the performance of research

        Manages processes regarding staff compliance with regulatory requirements concerning the performance of research

        Ensures that laboratory programs operate consistent with regulatory requirements concerning the performance of research


        TABLE 15. (Continued) Public health laboratory competency guidelines: Research domain

        RES 2.00. Ethical conduct: ensures the ethical and responsible conduct of research

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 2.01. Ethical conduct in research*

        Complies with policies,* processes, and procedures* related to ethical conduct in research

        Instructs others in policies, processes, and procedures regarding ethical conduct in research

        Ensures staff compliance to policies and procedures related to ethical research practices

        Oversees the policies, processes, and procedures for implementing and maintaining ethical research practices

        RES 2.02. Human and nonhuman subjects

        Complies with policies, processes, and procedures related to doing research in human and nonhuman subjects

        Instructs others in policies, processes, and procedures related to doing research in human and nonhuman subjects

        Ensures staff compliance to policies and procedures related to doing research in human and nonhuman subjects

        Oversees the policies, processes, and procedures for implementing and maintaining ethical practices* related to doing research in human and nonhuman subjects

        RES 2.03. Collaboration

        Complies with established agreements with collaborators

        Describes complexities regarding issues of collaboration, including authorship

        Ensures staff compliance with established agreements for research collaboration

        Builds research collaborations

        RES 2.04. Sharing research data

        Complies with established agreements pertaining to research data sharing and the use of intellectual property

        Describes issues that might arise pertaining to data ownership and the sharing of data

        Ensures staff compliance with established agreements regarding data sharing

        Establishes guidelines for sharing research data

        RES 3.00. Research foundation: integrates scientific and technical knowledge for use as a foundation for research

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 3.01. Literature searches

        Performs basic literature searches using a limited number of sources

        Performs complex searches, aggregating results from multiple sources

        Validates appropriateness of how searches are performed

        Rectifies gaps in data generated from searches

        RES 3.02. Critique of scientific literature

        Reads scientific and technical literature relevant to own work

        Assesses quality of literature and pertinence to own work

        Synthesizes scientific evidence derived from literature

        Evaluates scientific literature and data to determine impact on laboratory research programs

        RES 3.03. Statistical concepts and tests

        Recognizes meaning of common statistical concepts and tests

        Applies appropriate statistical concepts and tests in performance of research

        Interprets statistical tests and concepts used in literature

        Critiques statistical tests and concepts used in literature

        RES 3.04. Study designs

        Explains characteristics of common study designs

        Recognizes strengths and limitations of study designs

        Considers study design characteristics when planning research activities

        Evaluates evidence-based research guidelines to select or develop study designs

        RES 3.05. Scientific and technical concepts and procedures

        States scientific and technical concepts and procedures

        Discusses scientific and technical concepts and procedures

        Critiques scientific and technical concepts and procedures

        Generates novel scientific and technical concepts and procedures

        RES 3.06. Emerging trends

        States latest scientific and technical advances relevant to current research

        Discusses latest scientific and technical advances relevant to current research

        Identifies emerging trends in scientific and technical advances and possible impact to laboratory

        Analyzes emerging trends in scientific and technical advances to make decisions regarding impact on laboratory


        TABLE 15. (Continued) Public health laboratory competency guidelines: Research domain

        RES 4.00. Testing methodology development: develops new testing methodology

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 4.01. New testing methodologies

        States the purpose of each step in existing testing methodologies employed

        Describes limitations of existing methodologies

        Proposes concepts for improved methodologies

        Oversees plans for the development of new methodologies

        RES 4.02. Pilot testing, method validation,* and performance verification*

        Contributes to pilot testing, method validation, or performance verification

        Performs pilot testing, method validation, or performance verification

        Designs strategies for pilot testing, method validation, or performance verification

        Oversees pilot testing, method validation, and performance verification studies

        RES 4.03. New methodology application

        Participates in implementation of new methodologies

        Implements new methodologies into laboratory practice

        Manages implementation of new methodologies

        Oversees the implementation of new methodologies within the laboratory

        RES 5.00. Research project execution: conducts research to address a public health issue or answer a public health question

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 5.01. Research project design

        Explains how own tasks and activities support specific research projects

        Summarizes the public health issues and research questions addressed by specific research projects

        Designs research projects

        Oversees research projects to address the identified public health issues or questions

        RES 5.02. Experimental strategy and design

        States the purpose of each step performed in individual experiments

        Explains the overall experimental strategy

        Designs individual experiments

        Generates the overall experimental strategy and hypotheses for specific research projects

        RES 5.03. Conduct of experiments

        Uses established research protocols

        Provides input regarding research protocols and the conduct of experiments

        Develops research protocols to guide the conduct of experiments

        Oversees the conduct of experiments

        RES 6.00. Research data management, analysis, and application: conducts research according to professional standards of data management, analysis, and application

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 6.01. Data collection and quality*

        Records experimental procedures and data

        Monitors quality and integrity of recorded information and data

        Designs data collection and entry methods that meet data quality standards

        Develops policies, processes, and procedures to ensure data quality and integrity

        RES 6.02. Data management

        Complies with policies and procedures for data management

        Assists with the management of data for individual experiments

        Manages project data

        Oversees the management of research data for the laboratory

        RES 6.03. Data analysis and results interpretation

        Assists with data analysis of individual experiments

        Analyzes project data

        Interprets data for individual research projects

        Oversees data analysis plans and results interpretation for the laboratory's research projects

        RES 6.04. Data summaries

        Describes data tables and graphs

        Summarizes experimental data using multiple formats

        Develops outlines and formats for data summaries

        Critiques data summaries

        RES 6.05. Application of research findings to current research

        States laboratory's research findings

        Examines the laboratory's research data to determine its significance in the context of the scientific literature

        Implements integration of internal and external research findings into laboratory's research practices

        Oversees integration of internal and external research findings into revised research agenda, objectives, and/or experimental strategies


        TABLE 15. (Continued) Public health laboratory competency guidelines: Research domain

        RES 7.00. Dissemination of research findings: disseminates research findings

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 7.01. Meeting and conference presentations

        Attends institutional scientific presentations

        Presents research to colleagues within the organization or via poster at external events

        Presents research via oral presentation for discipline-wide audiences

        Serves as an invited speaker at external meetings and conferences

        RES 7.02. Manuscript preparation

        Assists in manuscript drafting and editing

        Drafts sections of research manuscripts

        Publishes as first author or senior author in journals of the discipline

        Publishes as senior author for multi-laboratory or multi-institutional research projects or in high-impact interdisciplinary journals

        RES 7.03. Manuscript peer review process

        Reads drafts of manuscripts submitted for peer review

        Informally critiques manuscripts submitted for peer review

        Participates in the peer review process as a formal reviewer

        Participates in the manuscript peer review process as member of the editorial board

        RES 8.00. Translation: translates research findings to public health practice

        Subcompetency

        Beginner

        Competent

        Proficient

        Expert

        RES 8.01. Translation of research findings into public health practice

        States research findings as they relate to current public health practices

        Describes implications of research findings on public health practices

        Directs translation of research findings to public health practices

        Oversees translation of research discoveries into meaningful changes in public health practices

        * This term is defined in Appendix B.

        A detailed plan for conducting a scientific procedure.



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