Morbidity and Mortality Weekly Report Supplement / Vol. 64 / No. 1 May 15, 2015
Competency Guidelines for Public Health Laboratory Professionals CDC and the Association of Public Health Laboratories
U.S. Department of Health and Human Services Centers for Disease Control and Prevention Supplement
CONTENTS CONTENTS (Continued)
Introduction...... 1 Safety Competency Guidelines...... 36 Methodology...... 2 Surveillance Competency Guidelines...... 45 Guiding Principles...... 5 Informatics Competency Guidelines...... 49 Competencies and Skill Domains...... 5 Microbiology Competency Guidelines...... 62 Quality Management System Competency Guidelines...... 8 Chemistry Competency Guidelines...... 68 Ethics Competency Guidelines...... 14 Bioinformatics Competency Guidelines...... 72 Management and Leadership Competency Guidelines...... 15 Research Competency Guidelines...... 74 Communication Competency Guidelines...... 20 Conclusion...... 78 Security Competency Guidelines...... 23 Acknowledgments...... 78 Emergency Management and Response Competency Guidelines.. 26 References...... 78 Workforce Training Competency Guidelines...... 29 Appendix A...... 82 General Laboratory Practice Competency Guidelines...... 32 Appendix B...... 83
The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA 30329-4027. Suggested citation: [Author names; first three, then et al., if more than six.] [Title]. MMWR Suppl 2015;64(Suppl-#):[inclusive page numbers].
Centers for Disease Control and Prevention Thomas R. Frieden, MD, MPH, Director Harold W. Jaffe, MD, MA, Associate Director for Science Joanne Cono, MD, ScM, Director, Office of Science Quality Chesley L. Richards, MD, MPH, Deputy Director for Public Health Scientific Services Michael F. Iademarco, MD, MPH, Director, Center for Surveillance, Epidemiology, and Laboratory Services
MMWR Editorial and Production Staff (Serials) Sonja A. Rasmussen, MD, MS, Editor-in-Chief Martha F. Boyd, Lead Visual Information Specialist Charlotte K. Kent, PhD, MPH, Executive Editor Maureen A. Leahy, Julia C. Martinroe, Christine G. Casey, MD, Editor Stephen R. Spriggs, Visual Information Specialists Teresa F. Rutledge, Managing Editor Quang M. Doan, MBA, Phyllis H. King, David C. Johnson, Lead Technical Writer-Editor Terraye M. Starr, Information Technology Specialists Jeffrey D. Sokolow, MA, Project Editor MMWR Editorial Board William L. Roper, MD, MPH, Chapel Hill, NC, Chairman King K. Holmes, MD, PhD, Seattle, WA Matthew L. Boulton, MD, MPH, Ann Arbor, MI Timothy F. Jones, MD, Nashville, TN Virginia A. Caine, MD, Indianapolis, IN Rima F. Khabbaz, MD, Atlanta, GA Jonathan E. Fielding, MD, MPH, MBA, Los Angeles, CA Patricia Quinlisk, MD, MPH, Des Moines, IA David W. Fleming, MD, Seattle, WA Patrick L. Remington, MD, MPH, Madison, WI William E. Halperin, MD, DrPH, MPH, Newark, NJ William Schaffner, MD, Nashville, TN Supplement
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, [email protected], 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 Studies of the PHL workforce have drawn attention to several concerns about staff training and projected turnover, both of The national network of governmental public health, which highlight challenges to maintaining a sufficient number environmental, and agricultural laboratories, referred to of highly skilled and competent workers. A 2011 national PHL collectively as public health laboratories (PHLs), is a vital part workforce characterization survey found that approximately of the U.S. public health infrastructure. These laboratories one third of PHL directors nationally expected 16%–25% perform multiple functions through provision of analytic of their workforce to retire, resign, or be released in the biological and/or chemical testing and testing-related services subsequent 5 years, while 12% anticipated losing 26%–50% of that protect human populations from infectious diseases, their workforce during that time period (6,7). Approximately foodborne and waterborne diseases, environmental hazards, 30% of the individual scientific staff respondents expected to treatable hereditary disorders, and other natural and human- continue working in a PHL for <5 years (6). These findings made public health emergencies (1–3). A well-trained largely reflect workforce demographics, because more than laboratory workforce is essential to ensuring that PHLs have half of scientific laboratory staff were aged >45 years (6). the capacity to carry out the critical activities that are needed to Important recruitment and retention challenges for the PHL safeguard the public’s health competently and effectively (4,5). workforce also have been identified, including the lack of
MMWR / May 15, 2015 / Vol. 64 / No. 1 1 Supplement established progressive job series (commonly termed “career Background ladders” in the PHL community) for PHL scientists (6–8) CDC and APHL have engaged collectively in multiple and the lack of adequate opportunities for training and laboratory workforce improvement efforts over the past professional development (6,7). Indeed, approximately 50% several years, providing the foundation for the development of laboratories reported no, minimal, or only partial capacity of these guidelines. More information about these efforts is to provide continuing education and training to their workers available at http://www.aphl.org. The 2011 launch of the (6,7). Lack of adequate training poses challenges because PHL Laboratory Efficiencies Initiative (27) was intended to assist scientists and managers require a range of scientific, leadership, PHLs in achieving long-term sustainability and resulted in and managerial development courses, ideally based on core recommendations from multiple forums to focus greater efforts competencies, to function effectively in their positions (9–11). on PHL workforce development. As part of these efforts, APHL Multiple national professional organizations, including collaborated with CDC in 2012 to develop a comprehensive the Institute of Medicine, the Association of Schools and set of competencies that built on APHL’s earlier work to draft Programs of Public Health, and the Public Health Foundation/ competencies for PHL professionals across several topic areas Council on Linkages Between Academia and Public Health (APHL, unpublished draft, 2011). The scope of that project Practice (Council on Linkages), among others, have endorsed then was expanded to include a broader range and depth of competency development as a means of strengthening the technical and nontechnical competencies, resulting in the public health workforce (12–15). Competencies improve the guidelines presented in this report. These guidelines for PHL workforce by providing a guiding framework for producing professionals were developed through the engagement of subject education and training programs, identifying worker roles and matter experts from APHL, CDC, state and local PHLs, federal job responsibilities, and assessing individual performance and environmental and agricultural laboratories, clinical laboratories, organizational capacity (12–18). and academia to ensure appropriate input and vetting. 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); Methodology competencies should be observable and measurable. Several public health professional disciplines have developed The PHL competencies were developed over a 2-year competencies, often through federal partnerships, to address period through a consensus process involving 108 subject workforce education and training needs (14,15,19–24), and matter experts participating through a variety of committees, competency-based curriculum development has been suggested workgroups, and teams (Box). In August 2012, CDC and as the ideal method for training public health workers and APHL established an 11-member CDC/APHL Steering public health students (10,11,13,18,25). In 2009, CDC Committee* to provide direction, guidance, and oversight to and APHL collaborated to develop guidelines for biosafety the overall competency development process. A 38-member laboratory competency (26), followed by development of this Project Planning Workgroup comprising CDC, APHL, and broader set of guidelines for PHL professional competency. PHL representatives encompassing a range of expertise (e.g., PHL leadership, informatics, microbiology, and environmental Purpose chemistry) was created through consultation with a nationally recognized expert in competency development and was The purpose of these guidelines is to outline the knowledge, charged with establishing the competency development skills, and abilities that public health laboratory professionals process. A 2-day meeting of the Project Planning Workgroup (principally scientists, managers, and leaders) need to deliver (which included the members of the CDC/APHL Steering the core services of PHLs efficiently and effectively. These Committee) facilitated by AlignOrg Solutions was held in guidelines establish core competencies that can help direct Atlanta, Georgia, in October 2012 to define the project scope workforce development efforts in PHLs in the United States. and target audience, prioritize expectations of stakeholders, Because the competencies are universal in nature for many discuss methods and criteria for writing competencies, laboratory disciplines, the guidelines also have potential value for determine the structure of the competencies, and develop a laboratories (including those not characterized as public health list of draft competency domains to represent the main subject laboratories) located in both developed and developing nations. areas in which PHL professionals operate.
* A list of all of the members of the various committees, teams, and workgroups appears beginning on page 93 of this report.
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Eleven Domain Teams then were established to develop well as competency sets for nonlaboratory audiences that had competencies for 14 draft competency domains; an additional application for PHL functions or specific domain areas (e.g., domain focused on ethics was developed later in the process. management, leadership, and workforce training). Although Most team leads and many members were drawn from the applicable literature was located for eight domain areas (Quality Project Planning Workgroup. Each team lead was responsible Management System, Management and Leadership, Ethics, for making recommendations regarding team membership Safety, Research, Emergency Management and Response, to the CDC/APHL Steering Committee and APHL staff, Workforce Training, and Informatics), limited material was who vetted potential members. Domain Team leads were found related to the remaining competency domains. Formal encouraged to recruit a diverse group based on employer type systematic review methods were not used because of the scarcity (government and nongovernment, and federal, state, and of available literature, especially regarding laboratory-specific local), geographic locale of employment, and years and range content. In December 2012, the Development Workgroup met of experience (laboratory scientists, managers, and leaders). A to draft a template document for each competency domain, total of 90 subject matter experts from CDC, state and local consisting of main competency statements comprising one PHLs, APHL, academic laboratories, clinical laboratories, the or more subcompetencies that were further defined by draft U.S. Department of Agriculture, and others served on the responsibility statements at one or more proficiency levels. various Domain Teams. The Workgroup members used the available literature when A Development Workgroup created template documents applicable but relied principally on their subject matter to assist the Domain Teams in constructing their respective knowledge and personal work experience as a basis for drafting competency sets and to ensure uniformity to the process. the template documents. This Workgroup, which comprised staff from CDC, During January 2013–April 2013, each Domain Team APHL, PHL, and AlignOrg Solutions, conducted literature held regular, facilitated conference calls to develop and refine reviews and Internet searches to identify related materials, their respective domain competencies, using the template including laboratory association guidelines and reports as document provided by the Development Workgroup as a
BOX. Timeline for development of the competency guidelines
August 2012: The CDC/Association of Public Health organizations and key stakeholders including PHL Laboratories (APHL) Steering Committee for the Public Health representatives, clinical laboratory representatives, APHL, Laboratory (PHL) Competencies Project was established. and CDC. October 2012: A Project Planning Workgroup comprising December 2013: The Adjudication Process Workgroup, CDC, APHL, and PHL representatives met to define the comprising APHL, CDC, and PHL representatives, scope and structure of the competencies. established the process for the adjudication of reviewer December 2012: The Development Workgroup comments by the Domain Teams. conducted a review of published literature and resources, January–March 2014: Domain Teams addressed including competency sets for non-PHL audiences. Outlines comments received during the vetting period via conference were crafted for use as a template for each domain. calls. The Ethics domain was crafted as a separate domain, January–April 2013: Eleven Domain Teams developed resulting in 15 total domains. draft competencies for 14 domains using the expertise of April 2014: The Harmonization of Domains Workgroup 90 subject matter experts from CDC, APHL, state and local reviewed major changes made by the Domain Teams to the PHLs, academic laboratories, clinical laboratories, the US draft competencies in response to reviewer comments and Department of Agriculture, and other entities. Each Domain resolved remaining redundancies and inconsistencies in Team held regular, facilitated conference calls to develop and approach and language among the competency domains. refine their competencies. April–July 2014: Small teams from the Harmonization April–November 2013: A Synthesis Workgroup assessed of Domains Workgroup finalized the competency domains. domain gaps and redundancies and harmonized language October 2014: The CDC/APHL Steering Committee across domains. reviewed the competency guidelines. November 2013–January 2014: The competencies February 2015: CDC reviewed and approved the final were vetted by volunteer representatives from external guidelines.
MMWR / May 15, 2015 / Vol. 64 / No. 1 3 Supplement starting point. Each team relied on member expertise to The extensive nature of the comments for the General arrive at consensus on all competencies, subcompetencies, Laboratory Practice and Emergency Management and and proficiency tier statements. The 14 proposed PHL Response domains prompted the CDC/APHL Steering competency domains were mapped against the core functions Committee to create dedicated teams for each of these of PHLs (2,3), the Council on Linkages Core Competencies domains. Several competencies and subcompetencies for for Public Health Professionals (14), and the CDC/Council the General Laboratory Practice domain had been extracted of State and Territorial Epidemiologists Applied Epidemiology previously from the Chemistry and Microbiology domains, Competencies (15) to assess congruence with these materials with additional content developed by a small work team. The and to identify gaps in the draft PHL competency domains. new General Laboratory Practice Domain Team included In April 2013, a six-person Synthesis Workgroup was representatives from the Chemistry, Microbiology, Quality established to review and assess the draft domain documents for Management System, Research, and Communication Domain gaps and overlaps in content and to harmonize language across Teams. Content for the Emergency Management and Response domains. During May–November 2013, the Workgroup’s domain had also been developed initially by the Chemistry efforts focused on developing definitions for each domain, and Microbiology Domain Teams. In light of the vetting continuing to harmonize content and address gaps and period comments, the Emergency Management and Response overlaps, developing an online survey tool for the competency domain competencies were rewritten by a dedicated team that validation process, and soliciting reviewers to evaluate one or included members from APHL’s Public Health Preparedness more competency domains. and Response department and the APHL Public Health Preparedness and Response Committee. Similarly, content Validation Process for the Ethics domain had been extracted from a number of existing domains, and three Domain Team volunteers formed The CDC/APHL Steering Committee identified the a new team to examine comments received. All Domain Teams organizations and agencies it wanted to target for involvement held as many conference calls as needed during January–March in the competency validation process. Following a solicitation 2014 to consider and address the vetting period comments. for reviewers, APHL staff contacted 139 potential reviewers In April 2014, a Harmonization of Domains Workgroup met on the basis of their knowledge and background in one or to review major changes that the Domain Teams had made to more particular domain areas. Of these, 75 were invited and the draft competencies in response to reviewer comments and to agreed to participate in the review phase. Reviewers were address any remaining overlaps in content and inconsistencies drawn from state and local PHLs, CDC, APHL, clinical in approach and language among the competency domains. laboratory organizations, and food-testing laboratories, as The Workgroup also resolved outstanding issues related to well as former PHL directors and other expert consultants. vetting period comments that the Domain Teams were unable Fifteen reviewers already had been involved in the competency to address individually in a consensus process. This workgroup development process in some capacity and offered to review comprised nine Domain Team leads, two CDC/APHL Steering domains that they did not take part in developing. Reviewers Committee members, the APHL project manager, and an were given 45 days during November 2013–January 2014 to invited representative of CDC. Workgroup members then split assess the validity of the content for the particular domain(s) into small teams and met via teleconference during April–July reviewed and to provide comments and recommendations for 2014 to finalize the competency domains. improvement through an online survey tool. The reviewers In total, the competencies were developed and reviewed by based their responses on their knowledge and experiences approximately 170 professionals with diverse backgrounds in laboratory practice. In December 2013, an Adjudication and experiences in laboratory science and public health. The Process Workgroup of APHL, CDC, and PHL representatives final draft of the competency guidelines was reviewed by the met to design and establish the process for adjudicating CDC/APHL Steering Committee in October 2014. The final reviewer comments, including a method for each Domain competency guidelines were reviewed and approved by CDC Team to document its response to each comment received. in February 2015. 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.
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Guiding Principles Competencies were written by using Bloom’s taxonomy as a framework; action verbs describing activities that are observable Scope and measurable were used to signify or relate to a hierarchy of The competency guidelines were developed specifically learning and actions (29,30). The hierarchy of responsibilities is for scientists working in PHLs. APHL defines PHLs as based on the science for competency development that has been governmental public health, environmental, and agricultural applied across numerous disciplines. Competencies typically laboratories that provide analytic biological and/or chemical are structured as broad statements that define what is expected testing and testing-related services that protect human of and can be demonstrated by the learner; therefore, specific populations against infectious diseases, foodborne and tasks or methods to achieve the competency at a particular waterborne diseases, environmental hazards, treatable proficiency level are not delineated. Each user is responsible for hereditary disorders, and natural and human-made public deciding the needed activities, which might vary substantially health emergencies (http://www.aphl.org/aboutaphl/ because of the diversity that exists within and across public aboutphls/pages/default.aspx). Although intended primarily for health laboratories. Consequently, competency statements do the continuum of scientist positions from laboratory assistant not refer to or include the frequency with which a responsibility to laboratory director, these competencies can be used by other is exercised. Nor, with rare exceptions, do they refer to specific PHL staff as well. In fact, all staff (including administrative guidelines, standards, or regulations, because these might differ and support staff, custodial staff, and information technology by discipline and type of laboratory. The competencies focus specialists) can apply competencies within the Security, on the knowledge, skills, and abilities required to perform a Safety, Emergency Management and Response, and Ethics range of activities in the PHL. The competencies convey the domains. Any staff members with responsibilities for data capability for a given behavior or skill, even if the opportunity entry, records management, client services, supply services, and to perform that skill or behavior is not available (e.g., to serve other nonbench functions would benefit from application of on national committees or instruct others in policies and competencies across additional domains depending on their processes). job function and responsibilities. A total of 122 competencies and 519 subcompetencies Although these competencies were developed expressly for were identified for the PHL workforce across 15 competency the PHL community, this does not preclude their broader domains: 1) Quality Management System, 2) Ethics, application to a variety of other work settings, because many 3) Management and Leadership, 4) Communication, of the skill sets are similar. Scientists, trainers/educators, 5) Security, 6) Emergency Management and Response, and leaders and managers in clinical laboratories, veterinary 7) Workforce Training, 8) General Laboratory Practice, laboratories, academic and private research laboratories, and 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, other laboratories may use these competencies as a basis for 13) Chemistry, 14) Bioinformatics, and 15) Research (Figure). further development of their workforce and local/institutional FIGURE. Schematic of competency domains for public health staff. Laboratories using these competencies should be mindful laboratory professionals* of federal, state, local, and institutional regulations and standards addressing topics such as safety and security when adopting competencies in practice. Micro- biology, Specialized Chemistry, Bioinformatics, Competencies and Skill Domains Research General Laboratory Practice, These guidelines were developed on the basis of the Dreyfus Safety, Surveillance, Cross-cutting Model of Skill Acquisition, which states that five progressive Informatics Ethics, Management and Leadership, stages of development are associated with skill proficiency Communication, Security, (18,28). Learners are able to handle additional responsibility Emergency Management and Response, General and adjust to different and more complex situations as they Workforce Training gain proficiency. For these competency guidelines, the Dreyfus Quality Management System Model was modified in that four proficiency tiers are used: beginner, competent, proficient, and expert. Descriptions of * Teams of subject matter experts develop general, cross-cutting technical, and the proficiency tiers are provided (Appendix A). specialized competencies, with a quality management system as the foundation of every activity.
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Full descriptions of these domains and listing of their Each subcompetency outlines a cumulative acquisition of competencies, subcompetencies, and responsibility statements skills, with each successive proficiency tier assuming that a are presented (Tables 1–15). A number and lettering schema is person has acquired the knowledge, skills, or abilities stated used to identify domains, competencies, and subcompetencies. in the lower proficiency tier for a given subcompetency. Domains are identified by three-letter initials (e.g., QMS), However, the amount of time required for a worker to achieve competencies are identified by the domain initials and an competency at a particular proficiency tier might be highly overall number (e.g., QMS 1.00), and subcompetencies are variable. In particular, the beginner phase could encompass further identified through expansion on the competency a very short time frame for some subcompetencies while numbering system (e.g., QMS 1.01 and QMS 1.02). requiring a longer time for others, depending on the specific Three types of domains are included in this competency action described. Regardless, all beginner tier statements set: 1) general domains that apply to the responsibilities of all assume that work will be performed under supervision. PHL professionals (i.e., Quality Management System, Ethics, Furthermore, all statements of the four proficiency tiers are Management and Leadership, Communication, Security, written under the assumption that work will be performed Emergency Management and Response, and Workforce according to standard operating procedures, processes, and Training); 2) cross-cutting technical domains that apply to policies approved by the administration of the laboratory all laboratory scientists regardless of the scientific discipline and in adherence to applicable regulations and accreditation in which they work (i.e., General Laboratory Practice, Safety, standards and guidelines. Surveillance, and Informatics); and 3) specialized domains Finally, no recommendation is made that any particular job that are specific to laboratory scientists working in particular title or academic degree is required for a particular proficiency scientific disciplines or specialized functional areas (i.e., tier, nor is the complexity of the knowledge, skills, and abilities Chemistry, Microbiology, Bioinformatics, and Research) for a given proficiency tier the same for all competencies. (Figure). The General Laboratory Practice domain is broadly For example, a PHL scientist could be at the beginner tier applicable because it includes general topics pertinent to for some subcompetencies while being at the competent or the laboratory workflow across a wide array of testing areas. proficient tier for others. Similarly, a person might acquire Many of these subcompetencies are not duplicated in the some expert tier competencies early in their career despite specialized domains. Consequently, the General Laboratory not having supervisory or management responsibilities. Many Practice domain serves two purposes: to be a companion to expert competency statements, however, apply to a person each specialized domain and to function as a quasispecialized occupying a position commensurate with a laboratory director, domain for testing activities not encompassed by the as significant experience and expertise are required. Microbiology or Chemistry domains. Because many topics are relevant to more than one competency domain, the Intended Use Harmonization of Domains Workgroup decided when to have intentional overlap of particular subcompetencies or These guidelines provide highly structured competencies topics across domains. For example, the General Laboratory intended to help ensure a capable, well-trained, and prepared Practice, Research, and Management and Leadership domains laboratory workforce. The competence of the PHL workforce include ethics-related competencies although there is a separate has a direct impact on the quality of the work output and Ethics domain. products required to protect the public’s health. Each For all domains, the competencies and proficiency tier competency and subcompetency within every domain might statements are context-driven. A given verb is not limited not apply to all laboratory staff. The competencies should to occurring at only one specific level of proficiency, as the be tailored and applied to the greatest extent possible to the complexity of the described action is determined by the individual user’s situation. Personnel can use the competencies context. In addition, some subcompetencies are similar across to assess their current skill level and define other areas in need of domains, in which case users should be mindful of the specific additional training, with a goal of achieving higher proficiency context. For example, sample collection, labeling, and handling over time. Laboratory directors and human resources staff are primary functions for both chemistry and microbiology. might find the guidelines helpful in creating standardized The subcompetency language for this group of activities is job descriptions, defining progressive job series, recruiting similar in the Chemistry and Microbiology domains, although new staff, assessing organizational capacity, and developing the specific actions (tasks) needed to achieve each level of performance objectives and appraisals that are aligned with the proficiency might be different between the testing disciplines. competencies. Laboratory managers may employ the guidelines
6 MMWR / May 15, 2015 / Vol. 64 / No. 1 Supplement as a reference for performance management strategies. The and the Clinical and Laboratory Standards Institute, some of competencies provide a framework for assessing performance which participated in the competency validation process. The and could be used to prepare for certification examinations competencies will be presented at meetings of public health and for meeting staff qualification requirements specified practitioners and laboratory professionals. The guidelines also by governmental laboratory personnel regulations. Finally, will be displayed on APHL’s website (http://www.aphl.org). educators and training developers may use the guidelines to The next stage of this PHL competency project will focus develop and refine PHL workforce development plans to assess on the development of tools and resources to aid in guideline and address training needs through the design of education implementation. These might include sample competency- and training programs. based job descriptions and examples of ways professionals It is important for users to review the definitions associated can demonstrate competency in a specific area; highlight with these guidelines (Appendix B). As terms might have case study examples of competencies in use; and provide different meanings in the context of different laboratory types, models for developing training and fellowship programs tied the terminology for this project has been standardized to to performance metrics and competencies. For example, the provide more clarity and ease in applying the competencies to Emerging Infectious Diseases Fellowship Program, which practice settings. In situations in which glossary terms contain is sponsored by APHL and CDC, could use guidance in more than one possible definition, the particular definition the toolkit to integrate these competencies into a training applicable to a domain is footnoted for that domain. program similar to the manner in which the CDC-sponsored Epidemic Intelligence Service program (31) integrated the Dissemination Applied Epidemiology Competencies (15). Tools and resources to support implementation will also be displayed on APHL’s CDC and APHL plan to disseminate these guidelines website (http://www.aphl.org) as they are developed. broadly to a variety of stakeholders, including, but not limited CDC and APHL also aim to develop a sustainability plan to public health laboratories, clinical laboratories, academia, to evaluate the adoption, use, and need for revision of these and laboratory scientist professional organizations such as the guidelines periodically. The Council on Linkages (14) and American Society for Clinical Pathology, the American Society the Clinical and Laboratory Standards Institute (32) provide for Clinical Laboratory Science, the Association of Food and models for competency and guideline revision that could Drug Officials, the Association of American Feed Control support this process. Officials, the Clinical Laboratory Management Association,
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Quality Management System As the first responsibility of the public health laboratory staff is to provide quality testing and services to support the health Competency Guidelines of the public and meet the many needs of their customers, this Purpose statement: The competencies in Quality demand for quality is superimposed on all aspects of laboratory Management System (QMS) address the knowledge, skills, operations. As such, a quality management system is the and abilities required for developing a laboratory’s culture of foundation for every other activity within this competency set. quality (Table 1). The essential elements integrate operations, Notes: The structure for this domain is based upon the 12 services, and infrastructure into a system that meets applicable quality system essentials (33). Multiple additional sources were regulatory standards, professional guidelines, and customer identified as support documents for this domain (34–40). As the requirements for ensuring and maintaining quality and foundational domain for these guidelines, all other competencies continually improving laboratory services. should be viewed within its context. However, this domain Introduction: QMS is a systematic approach for ensuring is systems-oriented. Other domains contain quality-related the consistent quality of the tests performed, the products subcompetencies that address “bench-level” quality indicators created, the data generated, and the results reported. Operating and activities and not the creation, maintenance, and evaluation within a quality system meets the needs and requirements of of a quality management system as presented here. The verb public health laboratories as well as the expectations of partners, “oversees” is used extensively in the Expert level. In this context, stakeholders, and users (internal and external customers). A “oversees” is a broad term that comprises the many functions QMS is more than quality assurance and quality control — it related to the management of policies, processes, and procedures also includes all the business processes of a laboratory that are to include creation, design, development, directing, monitoring, required to ensure quality. Adhering to quality standards for evaluation, and collaboration. laboratory operations helps laboratories generate consistent, reliable, and reproducible data and results.
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 Describes quality concepts and Demonstrates actions Sustains laboratory quality Oversees the development of quality good professional practice consistent with quality management system policies,* processes,* and concepts and good (QMS)* processes and procedures* for review and professional practice procedures to ensure maintenance of the QMS good professional practice
QMS 1.02. Organizational Identifies the laboratory’s Explains how the Manages organizational Coordinates organizational structure organizational structure that laboratory’s structure to ensure structure to ensure the QMS ensures quality organizational structure quality is well-integrated into all ensures quality levels of laboratory operations
QMS 1.03. Quality culture Describes the culture, Adheres to the culture, Advocates for a culture of Fosters a culture of quality, programs, and programs, and quality, safety, and ethics safety, and ethics communication processes communication regarding quality, safety, and processes regarding ethical practices* quality, safety, and ethical practices
QMS 1.04. Resources Identifies resources used to Requests resources to Makes resource allocation Ensures the ability to support the QMS support the QMS decisions to support the respond to unanticipated QMS needs for resources to support the QMS
QMS 1.05. Cost of quality* Describes how cost effective Analyzes quality measures Develops the procedures Creates an action plan to quality measures can improve to evaluate the costs of to estimate and compare address the impact of laboratory performance maintaining quality quality costs quality costs on regulatory compliance, customer* service, and the operating budget
See table footnotes on page 13.
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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 Responds to internal and Analyzes feedback and Oversees the system for internal and external external customer satisfaction data from measuring customer and customers inquiries and feedback internal and external user satisfaction customers
QMS 2.02. Customer services Describes the customer Adheres to roles and Develops procedures to Oversees the policies, services provided by the responsibilities in address customer needs, processes, and procedures laboratory to meet customer meeting customer needs, expectations, and for providing customer needs, expectations, and expectations, and requirements services that meet customer requirements requirements 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 Manages work area to Develops site-specific Oversees the policies, workplace training regarding ensure staff compliance workplace safety policies processes, and procedures safety and maintenance of the with safety requirements and procedures to develop, review, and physical environment maintain a safety plan that meets requirements
QMS 3.02. Facilities Describes the laboratory Monitors environmental Ensures security and Directs the process and design, escape routes, and controls* for good containment of staff, planning for facility design, workplace accommodations laboratory practice and samples,* laboratory modification, and testing capabilities supplies, and laboratory renovation equipment*
QMS 3.03. Waste management Describes waste management Applies waste Trains staff on the waste Ensures the waste policies, processes, and management policies, management plan,* management plan follows procedures processes, and including recycling and regulatory requirements procedures to activities disposal methods
QMS 3.04. Emergency Explains own role in emergency Trains staff in the Provides input on Establishes emergency management and response event mitigation, emergency management emergency management management and response preparedness, response, and plan for emergency and response policies, policies, processes, and recovery event mitigation, processes, and procedures preparedness, response, procedures and recovery
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 Describes education, training, Describes process Ensures each position has Designs a process to process and skills required for job required to verify staff the required determine required performance qualification and competencies, education, competencies, education, competency training, skills, training, skills, experience experience, and where and where applicable, applicable, certification,* certification and licensure and licensure* for each job title
QMS 4.02. Orientation and Participates in orientation and Ensures orientation and Facilitates orientation and Designs an orientation and end-of-employment end-of-employment end-of-employment end-of-employment end-of-employment processes processes are carried out processes program for each staff person
QMS 4.03. Training Participates in required training Ensures that training and Facilitates training and Oversees the policies, evaluation are carried evaluation processes processes, and procedures out for assigned duties for the training program
See table footnotes on page 13.
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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 Describes competence Participates in the Evaluates individual Oversees a competence assessment plan assessment plans development of an competence assessment assessment plan for the individualized competence plans organization assessment plan
QMS 4.05. Professional Participates in initial training Participates in continuing Manages the plan to provide Designs a plan to provide development plan related to assigned work education and professional development professional development position professional development opportunities to all levels of opportunities to all levels of opportunities staff staff
QMS 4.06. Performance Participates in the initial Participates in the Manages the performance Establishes a process for evaluation process performance evaluation ongoing performance evaluation process periodic performance process evaluation process evaluation
QMS 4.07. Recruitment, Describes the recruitment and Participates in recruitment Manages the recruitment, Develops recruitment, retention, and succession retention plan and retention planning retention, and succession retention, and succession plans plans 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 Participates in laboratory Manages laboratory Ensures that laboratory procurement process for procurement process procurement process procurement incorporates current work area organizational rules and collaboration with purchasing authorities
QMS 5.02. Inventory processes Describes the inventory Follows established Develops inventory Oversees inventory management processes used inventory management processes for laboratory management plan in current work area processes, including supplies, reagents, and receipt and inspection verification* of processes performance
QMS 5.03. Evaluation process Describes the process to Executes the process to Develops a process to Oversees a quality evaluate and provide evaluate and provide evaluate the satisfaction improvement plan for feedback to suppliers feedback to suppliers, with services and purchasing and inventory consultants, and products from suppliers, contractors consultants, and contractors
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 Describes the policies, Provides input on the Develops the processes Oversees the policies, decommissioning processes, and procedures for processes and and procedures for processes, and procedures equipment acquisition and procedures for equipment acquisition for equipment acquisition decommissioning equipment acquisition and decommissioning and decommissioning and decommissioning
QMS 6.02. Equipment Describes processes and Performs equipment Implements the Oversees the policies, qualification plan* procedures for equipment installation, operational, equipment qualification processes, and procedures installation qualification, and performance plan regarding the equipment operational qualification, and qualification procedures qualification plan performance qualification
See table footnotes on page 13.
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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 Performs procedures for Develops the processes for Oversees the policies, procedures for the the maintenance, equipment maintenance, processes, and procedures maintenance, troubleshooting, and troubleshooting, and for equipment troubleshooting, and service service and repair of service and repair maintenance, and repair of equipment equipment troubleshooting, service, and repair
QMS 6.04. Instrument and Describes calibration of Performs calibration of Establishes calibration Oversees calibration policies, equipment calibration instruments and equipment instruments and processes and processes, and procedures equipment procedures for for instruments and instruments and equipment 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 Applies workflow Develops evaluation, Oversees the policies, related to job position and processes according to modification, and design processes and procedures activities laboratory policies, of workflow processes for evaluating and processes, and and procedures modifying current workflow procedures processes and for developing new workflow processes
QMS 7.02. Process control Describes how processes are Participates in process Develops the process Oversees the process control controlled in work area control procedures control plan plan
QMS 7.03. Method validation* and Describes method validation Performs procedures for Develops method Oversees the policies, performance verification and performance verification method validation and validation and processes, and procedures processes processes performance verification performance verification for validation of new or processes and modified tests or materials procedures 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 Describes how the laboratory Applies the policies, Develops the policies, Oversees the document management system controls and manages processes, and processes, and management system to documents procedures for procedures for ensure staff compliance controlling and controlling and with internal policies, managing documents managing documents external regulations, and accreditation* requirements
QMS 8.02. Records management Describes how the laboratory Applies the policies, Develops the policies, Oversees the record system controls and manages records processes, and processes, and management system to procedures for procedures for ensure staff compliance controlling and controlling and with internal policies, managing records managing records external regulations, and accreditation requirements
See table footnotes on page 13.
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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, Complies with policies, Develops policies, Oversees the policies, processes, and procedures for processes, and processes, and processes, and procedures maintaining confidentiality of procedures for procedures for for ensuring confidentiality laboratory information maintaining maintaining of information and staff confidentiality of confidentiality of compliance with internally and externally internally and externally regulations and guidelines derived information derived information
QMS 9.02. Security Describes the policies, Complies with policies, Develops policies, Oversees the policies, processes, and procedures processes, and processes, and processes, and procedures related to securing procedures for securing procedures to ensure for securing information, information related to information information is secure including audits to meet assigned job tasks regulations and guidelines
QMS 9.03. Information integrity Describes the policies, Complies with policies, Develops processes and Oversees the policies, processes, and procedures for processes, and procedures to ensure the processes, and procedures ensuring integrity of procedures to ensure the integrity of information to ensure the integrity of information integrity of information 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 Recognizes NCEs Responds to NCEs Investigates NCEs, Oversees the policies, nonconforming events (NCEs) including the creation of processes, and procedures a corrective action plan related to NCEs
QMS 10.02. Documentation Describes the policies, Reports discovered NCEs Performs analysis of Oversees the policies, of NCEs processes, and procedures to records and reports of processes, and procedures record and report NCEs NCEs to identify trends to document NCEs and report NCE information to senior management and external entities
QMS 10.03. Investigation and Participates in NCE Leads the process of Assesses NCE Oversees the policies, root cause analysis* investigations and root cause investigating NCEs and investigations and root processes, and procedures analyses performing root cause cause analyses to for investigating NCEs and analyses improve processes performing root cause analyses
QMS 10.04. Notifications of Describes the policies, Responds to product Develops processes and Oversees the policies, recalls and technical bulletins processes, and procedures to recalls and technical procedures to address processes, and procedures address product recalls and bulletin notifications product recalls and to address product recalls technical bulletin notifications technical bulletin and technical bulletin notifications 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* Adheres to the quality Ensures the application of Develops the quality Oversees a comprehensive plan assessment plan the quality assessment assessment plan quality assessment plan plan to laboratory operations
QMS 11.02. External assessments Participates in external Performs external Develops the processes Oversees the policies, assessment activities assessment procedures and procedures to select, processes, and procedures enroll, and participate in related to external external assessments assessment
QMS 11.03. Internal audits Participates in internal audits Performs internal audit Develops the processes Oversees the policies, procedures and procedures for processes, and procedures internal audits related to internal audits
See table footnotes on page 13.
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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 Employs pre-examination, Develops processes and Oversees the policies, pre-examination,* examination, and procedures for processes, and procedures examination,* and postexamination quality determining pre- related to developing and postexamination* quality indicators examination, assessing quality indicators indicators examination, and postexamination quality indicators
QMS 11.05. Quality indicator data Describes the policies, Complies with policies, Develops the processes Oversees the policies, collection and analysis processes, and procedures processes, and and procedures for processes, and procedures related to collecting and procedures related to collecting and analyzing related to the collection and analyzing quality indicator collecting and analyzing quality indicator data analysis of quality indicator data quality indicator data data
QMS 12.00. Continual improvement: ensures mechanisms for continuous quality improvement Subcompetency Beginner Competent Proficient Expert QMS 12.01. Continuous Quality Describes the policies, Implements changes Develops the processes Oversees the policies, Improvement (CQI)* program processes, and procedures identified through the and procedures of the processes, and procedures related to the CQI program CQI program CQI program related to the quality improvement program
QMS 12.02. CQI activities Participates in CQI activities Follows CQI processes and Documents staff Oversees the policies, procedures for compliance with CQI processes, and procedures troubleshooting and activities that support the related to CQI activities documenting required CQI monitoring, CQI activities evaluation, and review processes
QMS 12.03. Corrective action* Describes the policies, Implements the processes Develops corrective action Oversees the policies, process processes, and procedures and procedures related processes and processes, and procedures related to corrective action to corrective action procedures to address related to corrective action quality improvement
QMS 12.04. Preventive action* Describes the policies, Implements the processes Develops the processes Oversees the policies, processes, and procedures and procedures related and procedures related processes, and procedures related to preventive action to preventive action to preventive action related to preventive action
QMS 12.05. Change Describes the process to Participates in the process Implements the change Oversees activities related to management* change laboratory policies, and procedures related management process, policy, process, and processes, and procedures to change management including communication procedural change of changes made to management, including established policies, evaluation of impact on processes, and organizational processes procedures 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.
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Ethics Competency Guidelines To carry out its mission, the public health laboratory must earn and maintain the public’s trust. As diligent stewards of Purpose statement: The competencies in Ethics address that trust and of public funds, all public health laboratory staff the knowledge, skills, and abilities needed to fulfill basic should act decisively and ethically in service to the public’s responsibilities to perform in a collegial and ethical manner health. Laboratory staff should apply ethical principles in all within a laboratory setting (Table 2). Ethical professional and aspects of their work, including respecting their colleagues, scientific behaviors are essential when working in the public customers, and populations they serve. Individual laboratory health laboratory to help ensure scientific integrity and sustain staff members should apply ethical principles in decision- effective relationships with stakeholders and the public. making to all aspects of their job performance and take Introduction: Ethics are principles or a set of values held responsibility for outcomes associated with their decisions. by a person or group, i.e., the rules or standards governing Ethics must exist at every level in the organization; and it the conduct of a person or the conduct of the members of a must be championed by every staff person, not just leadership. profession. These principles and rules include characteristics Notes: Multiple sources were identified as support documents such as personal accountability, maintaining confidentiality, for this domain (41–45). This domain is intentionally broad and ensuring the accuracy of testing results. These vital and includes examples of general and scientific ethics and but sometimes unspoken values, standards, and resulting practices in the glossary. It is the responsibility of each professional and scientific codes of conduct are critical to organization to further identify and detail the professional and establishing and maintaining a collegial environment in which scientific values and characteristics important to them. The scientific integrity is held in the highest regard. General Laboratory Practice, Research, and Management and Leadership domains also include ethics-related competencies.
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 Exemplifies integrity in Coaches staff in behaviors that Creates a culture where organizational culture interactions and activities exemplify integrity integrity is the foundation for all interactions and activities
ETH 1.02. General ethical Applies ethical principles and Serves as a role model of Ensures staff compliance with Oversees the policies, practices* professional rules of conduct ethical behavior by policies and procedures processes,* and procedures* to the workplace consistently conforming to related to ethical principles related to ethical principles the highest ethical standards and professional rules of and professional rules of and practices conduct conduct
ETH 1.03. Stewardship of Acts as a good steward of Identifies methods to improve Ensures that the use of public Oversees the policies, resources public funds and resources stewardship of resources funds and resources meet the processes, and procedures to policies for stewardship 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 Instructs others in policies, Ensures staff compliance with Oversees the policies, test results and findings processes, and procedures policies and procedures processes and procedures to regarding scientific integrity regarding scientific integrity ensure practices are of test results and findings of all results and findings consistent with guidelines on scientific integrity
ETH 2.02. Scientific ethics Applies scientific ethics and Serves as a role model of Ensures staff compliance with Oversees the policies, rules of conduct to the scientific ethical behavior and policies and procedures processes, and procedures workplace rules of conduct by related to scientific ethics and related to scientific ethics and consistently conforming to rules of conduct rules of conduct the highest scientific standards and practices
* This term is defined in Appendix B.
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Management and Leadership management and leadership are both critical to accomplishing the core functions of public health laboratories (2,3). Competency Guidelines All staff members require a certain degree of management Purpose statement: The competencies in Management and and leadership skills. The scope of work performed by public Leadership address the knowledge, skills, and abilities related health laboratories is complex and, therefore, requires staff to managing staff (supervision), the science and practice of members who have the crucial leadership and management achieving results using available resources (management), and knowledge and skills to be effective in such an environment. the process of influencing the actions of a person or group to Public health laboratories have a great need to develop these attain desired objectives (leadership) (Table 3). skill sets, as there is a severe and continuing shortage of Introduction: Management and leadership are distinct and scientists qualified to assume management and leadership complementary roles, both of which are necessary for the success positions. This situation is made more challenging because of an organization. They can be distinguished in a number of staff members are rarely provided formal training in these areas ways (46). Leadership establishes the purpose and strategic through degree, fellowship, or other programs. direction of the organization. Leading involves innovating, Notes: Multiple sources were identified as support influencing, and motivating. Leadership asks “what” and “why” documents for this domain (4,10,11,14,15,35,37,46,47), and mainly works with persons and their interrelationships. which supports all other domains in these guidelines. This Management establishes the systems and processes of the domain is intended for all staff, not just those with managerial organization. Managing involves administering, planning, or leadership positions or job titles. It is sometimes difficult to organizing, and coordinating. Management asks “how” and separate a skill, behavior, or process as belonging exclusively “when” and mainly works with systems, processes, mechanisms, to either management or leadership. As such, leadership models, and structures. Leadership challenges and improves subcompetencies are interwoven throughout the domain and accepted policies and processes and ensures alignment with the are not limited to those within the Leadership competency mission and vision of the laboratory (i.e., strives to do the right (MLD 5.00). Ethics-related competencies are included in things). Management works within accepted administrative this domain that correlate with competencies found in the policies and processes to accomplish the mission and vision Ethics domain. of the laboratory (i.e., strives to do things right). Effective
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, Contributes to activities that Explains the relationships Exemplifies the mission, Develops the mission, vision and values support the mission, vision, between activities that vision and values for the and values for the and values of the laboratory support the mission, vision, laboratory laboratory and values
MLD 1.02. Organizational Describes the organizational Coordinates laboratory Adapts organizational Oversees a process* to structure structure of the laboratory program* structure to meet structure to meet the ensure organizational organizational needs laboratory’s mission and structure meets the directives for laboratory laboratory’s mission and programs directives for laboratory programs
MLD 1.03. Laws and Complies with laws and Coordinates program Manages laboratory Ensures that laboratory regulations for laboratory regulations related to activities according to laws programs consistent with programs are consistent operation laboratory operations and regulations related to laws and regulations related with federal, state, and local laboratory operations to laboratory operations laws and regulations
MLD 1.04. Technical Works collaboratively on Implements technical and Develops processes and Oversees the policies,* operations management technical and operational operational plans procedures to manage processes, and procedures* planning technical operations related to the development and evaluation of technical operations
MLD 1.05. Emergency Describes emergency Operates within assigned Manages the emergency Oversees laboratory-wide management and response management policies and roles when carrying out management and response emergency management procedures emergency management plan at the programmatic and response and response duties level See table footnotes on page 19.
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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 Describes the processes for Participates in improvement Manages the improvement of Oversees funding and operational services introducing improved of analytical and operational analytical and operational stakeholder relationships analytical and operational services services needed to implement and services improve analytical and operational laboratory services
MLD 1.07. Quality* testing Describes quality principles Explains the importance of Evaluates the quality of Oversees the policies, and services providing quality laboratory services for continued processes, and procedures testing and services quality improvement to ensure the quality of laboratory testing and services
MLD 1.08. Customer* service Supports customer service Evaluates customer service Identifies strategies and Oversees the policies, needs satisfaction and trends activities to improve processes, and procedures customer service to ensure the laboratory maintains a customer focus
MLD 1.09. Project Uses basic project Trains staff on project Directs the management of Oversees project management* management concepts* management techniques projects at the management across the and tools programmatic level laboratory
MLD 1.10. Program Contributes data for program Analyzes data to assist in the Directs activities to monitor Oversees the policies, effectiveness effectiveness monitoring monitoring and evaluation and evaluate the processes, and procedures and evaluation of program effectiveness effectiveness of laboratory regarding the programs 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 Describes concepts pertinent Compiles important issues, Prepares internal policies Oversees the internal policy development to developing internal lists of stakeholders, and based on evaluation of development process policies various options and short- and long-term solutions for internal policy consequences of potential development policies
MLD 2.02. Internal policy Complies with documented Implements internal policies Ensures staff compliance with Oversees internal policy implementation internal policies and for a laboratory program laboratory-wide policies implementation and staff guidelines compliance
MLD 2.03. Internal policy Reviews internal policies for Develops amendments or Evaluates internal policies Oversees the review process review revisions and updates updates to internal policies for internal policies
MLD 3.00. Financial management: ensures sound financial management Subcompetency Beginner Competent Proficient Expert MLD 3.01. Budgets Complies with budgetary Monitors staff compliance to Reconciles budget, Oversees budgets, including guidelines the budget expenditures, and income development and staff compliance with agency and legislative mandates
MLD 3.02. Revenue and Describes revenue sources Tracks revenue and income Manages revenue and Ensures that necessary income associated with individual for a laboratory program income for the laboratory revenue and income is activities secured
MLD 3.03. Expenditures Adheres to guidelines and Tracks expenditures for a Ensures staff compliance with Oversees the policies, limits for expenditures laboratory program guidelines and limits for process, and procedures expenditures related to the cost of operations
See table footnotes on page 19.
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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 Uses designated financial Integrates financial Optimizes the financial Oversees the policies, management process management tools management tools for a management system for the processes, and procedures laboratory program laboratory related to financial management and fiduciary responsibility
MLD 3.05. Resource Uses workplace resources Optimizes use of laboratory Manages resources for the Oversees the policies, management efficiently program resources laboratory 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 Complies with human Enforces human resource Manages human resource Oversees the policies, policies resource rules and requirements and policies requirements and policies processes, and procedures requirements* related to the human resource system
MLD 4.02. Equal Employment Describes the EEO process Promotes EEO requirements Manages EEO requirements Oversees the policies, Opportunity (EEO)* process and policies and policies processes, and procedures related to EEO in the human resource system
MLD 4.03. Position Provides input into job Evaluates position Manages the development Oversees a system of position descriptions description content descriptions for congruency and implementation description development with job functions processes for position and implementation to descriptions maximize staff competence and meet operational requirements
MLD 4.04. Staff licensure* Describes the basic Maintains a process to ensure Performs ongoing gap Ensures staff compliance with education, skills and that staff meet licensure analysis to address staff licensure laws and certifications* for laboratory requirements licensure requirements regulations staff licensure requirements
MLD 4.05. Competency Participates in competency Manages the competency Evaluates the competency Ensures that staff assessment assessments assessment program assessment program competence levels are commensurate with job functions
MLD 4.06. Performance Participates in Integrates performance Monitors staff progress on Ensures that a system is in feedback communications with peers feedback into work routines agreed-upon performance place that values honest and supervisors regarding parameters and open communication performance about performance
MLD 4.07. Performance Describes how the formal Administers performance Evaluates effectiveness of the Oversees the continuous appraisal process performance appraisal appraisals performance appraisal improvement of the process impacts laboratory process in improving performance management operations laboratory productivity and system practice
MLD 4.08. Conflict resolution Identifies the need for Resolves conflicts in a fair and Integrates mechanisms to Oversees the policies, management intervention equitable manner support cooperation and processes, and procedures in conflict resolution manage conflict across the to ensure the fair and laboratory equitable resolution of conflicts
See table footnotes on page 19.
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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 Describes the steps of the Administers progressive Analyzes the use of Ensures that the progressive discipline progressive discipline discipline progressive discipline within discipline system is used to process the laboratory mitigate disciplinary issues
MLD 4.10. Professional Participates in professional Recommends professional Assesses professional Oversees the policies, development development activities development activities development gaps to processes, and procedures ensure and support staff to encourage and address competency development professional development
MLD 4.11. Staff advancement Explains the policies and Recommends staff for Develops criteria for staff Ensures that staff function in procedures related to staff advancement advancement roles commensurate with advancement experience, skill set, and proficiency
MLD 4.12. Succession Recognizes the importance Implements staff Develops succession plans Oversees the policies, planning of succession planning development plans that that consider current and processes, and procedures align with the laboratory’s future needs related to the creation and succession plan implementation of succession plans
MLD 5.00. Leadership: models leadership behavior Subcompetency Beginner Competent Proficient Expert MLD 5.01. Ethical practices* Applies ethical principles and Serves as a role model of Ensures staff compliance with Fosters the policies, and professional code of a professional code of ethical and professional the policies and procedures processes, and procedures conduct conduct to the workplace behavior by consistently related to ethical practices related to ethical practices conforming to the highest and a professional code of and a professional code of standards and practices conduct conduct
MLD 5.02. Communication Employs active Communicates information Ensures the open and Fosters a culture of open and communication skills and feedback to colleagues frequent exchange of frequent communication and management staff communication between laboratory staff
MLD 5.03. Teamwork and Describes the value of Collaborates with team Leads cross-functional teams Creates a workplace collaboration collaboration in the members within a to accomplish projects environment that workplace laboratory program encourages teamwork and collaboration
MLD 5.04. Diversity* culture Explains the value of having a Promotes a diverse workforce Develops programs that Fosters a culture where diverse workforce support a culture of diversity is valued diversity
MLD 5.05. Staff engagement* Participates in activities to Implements activities that Develops programs that Fosters a culture of staff support the laboratory’s support staff engagement support a culture of staff engagement and goals engagement commitment
MLD 5.06. Staff recognition Participates in staff Evaluates the effectiveness of Develops staff recognition Fosters a culture that ensures recognition programs staff recognition programs programs staff recognition
MLD 5.07. Coaching* and Describes the benefits of Develops a pool of potential Establishes coaching and Fosters a culture where mentoring* coaching and mentoring coaches and mentors for mentoring programs coaching and mentoring are staff deeply-rooted
MLD 5.08. Critical thinking* Develops basic critical Applies critical thinking to Leads critical thinking Fosters an environment that thinking skills develop effective solutions activities to achieve integrates critical thinking to problems improvements in laboratory processes
See table footnotes on page 19.
18 MMWR / May 15, 2015 / Vol. 64 / No. 1 Supplement
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 Incorporates systems Fosters an environment that when approaching projects thinking into directing integrates systems thinking and problem solving laboratory operations
MLD 5.10. Strategic thinking* Describes strategic thinking Provides input into strategic Integrates strategic thinking Fosters an environment that thinking and decision- into decisions and integrates strategic thinking making processes long-term planning regarding laboratory operations
MLD 5.11. Change Describes the value of Implements change Leads the development of Fosters a culture that management* change management initiatives change management continuously assesses within a laboratory program initiatives with the change opportunities for laboratory sustaining the mission
MLD 5.12. Advocacy Educates external Collaborates with external Identifies gaps in Develops strategies to stakeholders on the mission, stakeholders engagement with external engage external vision, and activities of the stakeholders to support the stakeholders to accomplish laboratory activities of the laboratory the mission, vision, and activities of the laboratory
MLD 5.13. External policy Describes impacts of external Communicates with Promotes external policy Fosters relationships with development policies related to the stakeholders to exchange development to support the strategic partners to secure organization’s mission policy input organization’s mission and laboratory-inclusive policies vision consistent with the organization’s mission and vision
MLD 5.14. Promotion of the Recognizes the need for Identifies potential Facilitates participation of key Fosters partnerships with key health of populations partnerships to promote the partnerships to promote the stakeholders to promote the stakeholders to promote the health of populations health of populations health of populations health of populations affected by laboratory services
* This term is defined in Appendix B.
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Communication Competency Effective internal and external communication is necessary for the optimal operation of the public health laboratory. Internal Guidelines communication between staff is essential to satisfy the organization’s Purpose statement: The competencies in Communication goals and quality management system. External communication address the knowledge, skills, and abilities necessary to is necessary to disseminate public health information and to disseminate information in a clear and concise manner highlight the importance of laboratory contributions in support appropriate to a given audience (Table 4). Communication of public health. Public health laboratories are often called upon might occur in writing, orally, or nonverbally, and it might to convey the mission, operational features, and test services (the take place in person or through electronic means. “why,” “how,” and “what”) of their laboratory. These tasks involve Introduction: Communication is the application of written, engaging traditional and nontraditional partners and are critical verbal, and nonverbal methods and resources, either in person to ensuring continued interest and support of the public health or through available technologies, to convey information. laboratory system. Although transmission of information is critical, assurance Notes: Multiple sources were identified as support the information is accurate, clear, tailored to the audience, documents for this domain (14,15,48,49). Communication and prepared with linguistic aptitude and cultural sensitivity skills are pervasive throughout other domains, including skills is equally important. 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.
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 Identifies key messages for Applies logical structure* to Incorporates tools to Establishes content, style, communication written communication written communications organize and present tone, and form for written detailed or complex messages according to information* target audience
COM 1.02. Oral Identifies key messages for Applies language and tone in Selects communication Establishes content, style, communication oral communication oral communications methods* tailored to target tone, and form for oral tailored to target audience audience 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 Provides undivided attention Summarizes the dialogue to Provides feedback based on Facilitates dialogue exchange exchange to the other participants in a show understanding the dialogue summary through paraphrasing and dialogue clarification of critical points
COM 2.02. Contextual clues Exhibits open posture and Applies range of body Exhibits active listening Incorporates multiple facial expression to engage language cues to enhance during the dialogue behaviors of engagement the other participants in a the exchange exchange during dialogue exchanges dialogue
COM 2.03. Respectful Defers judgment during Provides counterpoints while Coaches others in techniques Facilitates respectful dialogue exchange dialogue exchanges being respectful of of respectful exchange among participants in the disagreements exchange
See table footnotes on page 22.
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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 Follows written directions Applies knowledge acquired Adapts concepts from written Extrapolates information comprehension from written text to text for use in new from written text to develop situations situations 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 Describes the laboratory’s Selects laboratory’s Evaluates existing and Establishes technology capability and partner’s technological technology options to align potential technology to policies* that integrate with capabilities with partner’s capabilities align with partner’s the partner’s capabilities capabilities
COM 4.02. Use of technology Describes employer’s policies Uses designated technology Manages technology policies Evaluates the effectiveness of and procedures* for sharing for sharing information and procedures used for the technology used for information sharing information sharing information
COM 5.00. Communication professionalism: ensures professionalism in communication with customers* and stakeholders Subcompetency Beginner Competent Proficient Expert COM 5.01. Professional Uses tone of voice and Displays professional Monitors interactions with Establishes policies for attitude language tailored to demeanor in all situations customers and stakeholders professional customer and interactions with customers with customers and to ensure they are stakeholder interactions and stakeholders stakeholders conducted professionally
COM 5.02. Information Provides information based Determines information Ensures that information Develops overarching system exchange on policies and procedures needs through collaboration exchange policies, for exchange of information to meet the needs of with customers and processes, and procedures to meet the needs of customers and stakeholders stakeholders are followed to meet the customers and stakeholders needs of the customers and stakeholders
COM 5.03. Information Shares information as Selects information to share Develops information to Creates opportunities for sharing opportunities directed share 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 Creates drafts of written Revises written reports Establishes policies, written reports reports processes, and procedures for written reports
COM 6.02. Oral presentations Organizes information for Creates drafts of oral Revises oral presentations Establishes policies, oral presentations presentations 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 Describes the risk Adheres to the risk Ensures staff compliance with Establishes policies, communication plan communication process communication plan the risk communication processes, and procedures plan related to the risk communication plan
See table footnotes on page 22.
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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 Lists basic emergency Identifies specific emergency Develops emergency Collaborates with agency information information for target information for target information and messages leaders and partners to audience audience tailored to target audience deliver emergency information and messages tailored to target audience
COM 7.03. Empathetic risk Describes empathetic risk Delivers empathetic Creates empathetic Evaluates empathetic communication communication concepts messaging in high-risk messaging in high-risk messaging for high-risk situations or emergencies situations and emergencies 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 Coordinates opportunities for Identifies opportunities to Develops opportunities to of the public health promoting the public health promote the public health promote the public health laboratory and system laboratory and system laboratory and system laboratory and system
COM 8.02. Communication to Supports the development Presents communication Develops communication Manages the policies, educate and inform and distribution of materials to explain the materials to explain the processes, and procedures communication materials importance of the public importance of the public regarding communication about the public health health laboratory health laboratory materials to explain the laboratory importance of the public health laboratory
COM 8.03. Storytelling Shares approved public Incorporates use of stories Develops stories that convey Evaluates the impact of health laboratory stories when communicating the information highlighting storytelling in promoting impact of public health the impact of public health the public health laboratory laboratory work laboratory work
COM 8.04. Marketing strategy Participates in marketing Implements the marketing Manages the marketing Oversees the marketing strategies strategy for the public strategy for the public strategy for the public health laboratory health laboratory 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 Adheres to agency media Identifies situations where Monitors the application of Oversees media relations policies and strategies relations policies and agency media relations agency media relations policies and strategies procedures policies and strategies apply policies and strategies
COM 9.02. “Plain talk”* Describes the value of using Applies “plain talk” during Develops “plain talk” Translates highly technical “plain talk” public and media language for media and concepts using “plain talk” interactions public communications for media and public communications
COM 9.03. Key messages Describes the value of using Applies key messages during Develops key messages for Oversees delivery of key key messages public and media media and public messages on complicated, interactions communications high-risk topics
* This term is defined in Appendix B.
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Security Competency Guidelines that ensures that operations are carried out in an environment that is secure and protected at all times. Each person must Purpose statement: The competencies in Security address consistently carry out their responsibilities to ensure the the knowledge, skills, and abilities necessary to ensure a effective application of security practices. secure, protected working environment that meets or exceeds To meet its mission, the public health laboratory must ensure applicable regulatory requirements and guidelines (Table 5). the security of the environment, infrastructure, staff, and of the Introduction: Security is a compilation of elements that samples and sensitive information with which it is entrusted. include physical, operational, information, and staff protection Thus, the knowledge, skills, and abilities included in this with the intent to safeguard personnel and to protect assets and domain must be integrated into all technical and nontechnical data from unauthorized access, misuse, loss and/or theft. This is aspects of staff members’ job performances. accomplished through the implementation of a comprehensive Note: Multiple sources were identified as support documents security management system, founded on accepted practices, for this domain (50–52).
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 Interprets security concepts Develops security policies, support of organizational to adapt policies* and processes,* and procedures, goals procedures* to support including security standards organizational goals
SEC 1.02. Risk assessment† Describes the risk assessment Identifies assets,* Manages the risk assessment Develops policies, processes, process and procedures vulnerabilities, and process and procedures regarding potential threats for risk assessment incorporation into risk analyses
SEC 1.03. Risk mitigation plans Describes the policies and Applies risk mitigation plans Manages the implementation Develops policies, processes, procedures regarding risk of risk mitigation plans and procedures regarding mitigation plans risk mitigation planning and implementation
SEC 1.04. Risk mitigation plan Describes policies, processes, Implements processes and Develops procedures based on Develops policies, processes, reporting and procedures for risk procedures for risk established processes for risk and procedures for risk mitigation plan reporting mitigation plan reporting mitigation plan reporting 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 Recommends elements to be Designs laboratory’s security Advises organizational documented in the security included in the security plan plan in collaboration with leadership on the security plan to address risks subject matter experts plan, including acceptability of identified risks
SEC 2.02. Security plan Describes security plan Implements the security plan Evaluates the objectives and Advises organizational implementation elements applicable to job functions of the security leadership on selecting system security strategies to protect assets and on monitoring the performance of the security plan
See table footnotes on page 25.
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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, Monitors security operations Manages security operations Oversees security operations processes, and procedures to ensure defined for maintaining security protection measures are based on the degree of risk
SEC 2.04. Inventory records* Completes inventory records Audits inventory records Creates tools to manage Develops policies, processes, related to security plans to comply with the inventory records and procedures to manage laboratory’s security plan inventory records
SEC 2.05. Security incident* Reports security incidents Evaluates reported security Implements processes and Develops policies, processes, response incidents procedures related to and procedures for security security incident response incident response and and reporting reporting
SEC 3.00. Physical security: ensures that physical security is maintained Subcompetency Beginner Competent Proficient Expert SEC 3.01. Physical security Describes the physical Trains staff on policies, Solves difficult and complex Directs the resolution of major infrastructure* security infrastructure processes, procedures, and physical security problems conflicts in physical security related regulations policy and program regarding physical security objectives infrastructure
SEC 3.02. Physical security Describes physical security Applies physical security Manages the implementation Advises organizational access controls* access control policies, access control procedures of physical security access authorities on methods for processes, procedures, and and systems control policies, processes, enhancing effectiveness systems procedures, and systems 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 Describes personnel security Addresses problems or Interprets personnel security Develops policies, processes, concepts* concepts questions involving concepts to adapt processes and procedures that personnel security concepts and procedures to support incorporate personnel organizational goals security concepts into personnel security program
SEC 4.02. Personnel security Complies with the Implements the personnel Solves difficult and complex Directs the resolution of program laboratory’s personnel security program personnel security major conflicts in personnel security program problems security policy and program objectives
SEC 4.03. Investigations Collects information* for Analyses actions regarding Determines actions to be Develops policies, processes, personnel security personnel security matters taken on personnel security and procedures related to investigations requiring investigation investigations personnel security investigations
See table footnotes on page 25.
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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, Applies information security Interprets information Develops policies, processes, and procedures related to concepts, including security concepts to adapt procedures, and information security principles of confidentiality, policies, processes, and organizational standards for integrity, and availability procedures to support information security to (CIA)* organizational goals meet organizational goals
SEC 5.02. Risk identification Describes the risks associated Identifies risks associated Implements processes and Develops polices, processes, and prioritization with the laboratory’s with the laboratory’s procedures for prioritizing and procedures for sensitive information* or sensitive information and risks associated with the identifying, prioritizing, and technology related to the technology, including the laboratory’s sensitive controlling sensitive job being performed methods of control information and information and technology technology, including the methods of control
SEC 6.00. Transportation security program: implements a transportation security plan* Subcompetency Beginner Competent Proficient Expert SEC 6.01. Transport security Complies with transport Audits transport records Creates transport security Establishes policies and security policies, processes, procedures processes to specify which and procedures 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.
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Emergency Management and responsibility to detect and respond to real or potential biological, chemical, or radiological threats. Response Competency Guidelines Public health laboratory staff members are responsible for Purpose statement: The competencies in Emergency the recognition, response, and management of emergency Management and Response address the knowledge, skills, events and situations directly impacting laboratory operations and abilities needed to mitigate, prepare for, respond to, and surge testing. Staff members provide outreach, training, and recover from laboratory-specific emergency events and and communication with the sentinel clinical laboratories, situations (Table 6). first responders, and other stakeholders as a critical role in Introduction: Emergency Management and Response jurisdiction-wide emergency management and response. is a four-phase process involving mitigation, preparedness, Notes: Multiple sources were identified as support documents response, and recovery for emergency events and situations for this domain (21,26,51,53–57). This domain is intended to that have a direct impact on laboratory operations and surge be used in conjunction with the Safety and Communication testing. This domain recognizes the public health laboratory’s domains and is based on the Federal Emergency Management mandate to provide emergency response support to external Agency’s (FEMA) mission areas for national preparedness (55). partners. Emergency management and response encompasses Critical activities in each phase frequently overlap. This domain events such as natural disasters or public health emergencies, does not address accidents, spills, or other similar occurrences facility or operation failures, in addition to the public health within the laboratory, which are included in the Safety domain.
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 Assesses potential Develops the plan to reduce Manages the policies†, vulnerabilities and risks in vulnerabilities and risks in and ensure against risks in processes†, and procedures† their work area the organization the organization to reduce and ensure against risks in the organization
EMR 1.02. Incident response Describes the incident Implements the incident Verifies staff compliance Manages facility-wide plan† response plan response plan while with the incident response implementation of the maintaining safety and plan while ensuring the incident response plan security of staff and safety and security of staff facilities and facilities
EMR 1.03. Emergency Recognizes emergencies and Recognizes emergencies and Evaluates staff’s ability to Creates an environment that situation recognition other incidents† in their other incidents in the recognize emergencies and supports the recognition and work area that should be organization that should be other incidents that should reporting of emergencies reported reported be reported
EMR 1.04. Emergency alarms† Recognizes significance of Instructs others on the Evaluates staff’s knowledge Collaborates with persons and alarms significance of alarms of alarm significance agencies to develop site-specific or unique alarm systems
EMR 1.05. Laboratory assets† Describes the assets in their Inventories the assets in the Identifies the assets in the Manages the assets in the important during an work area facility facility facility emergency
EMR 1.06. Evaluation of Summarizes the emergency Assesses emergencies to Interprets data from Shares findings of the emergency events evaluation process determine the extent of evaluation of emergencies evaluation of, and responses each incident to develop specific to, emergency events with response to each incident stakeholders to enhance mitigation
See table footnotes on page 28.
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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 Explains the laboratory’s Assists with development Manages development and Oversees laboratory’s emergency events emergency response plan† and implementation of the implementation of the emergency response plan, and Continuity of laboratory’s emergency emergency response plan including implementation of Operations Plan (COOP)† response plan and COOP and COOP for an individual the COOP with external area of responsibility partners
EMR 2.02. Incident command Demonstrates awareness of Completes higher-level Implements the ICS by Serves at a leadership level in system (ICS)† the ICS by completing a FEMA-approved courses to completing high-level the ICS FEMA-approved explain the operation and FEMA-approved courses introductory course management of the ICS and internal training courses and exercises
EMR 2.03. Emergency Participates in emergency Contributes to the Conducts emergency Oversees the collaboration response training response training, development of emergency response training, with stakeholder agencies to exercises, and drills response training, exercises, and drills in sponsor and conduct exercises, and drills collaboration with training, exercises, and drills, stakeholder agencies ensuring proper resources are available
EMR 2.04. Emergency Describes requirements† for Implements organizational Develops internal policies Oversees the collaboration notification notification of emergencies plans and policies for and procedures for with stakeholders and and other incidents notification of emergencies notification of emergencies agencies to develop and according to organizational and other incidents and other incidents implement plans and policies plans and policies for notification of emergencies and other incidents
EMR 2.05. Identification of key Describe partners and their Interacts with partners on Engages partners to sustain Develops new partnerships to partners relationships with the staff relationships and ensure ensure effective emergency institution effective response response
EMR 2.06. Execution of Describes emergency Updates agreements with Trains staff on agreements in Negotiates agreements agreements agreements between the partners to ensure place to ensure emergency between partner institution and other emergency response response capability organizations to ensure partners capability emergency response capability
EMR 2.07. Emergency Explains how the laboratory Describes the plans, policies Develops the organizational Oversees the collaboration preparedness and response interacts with emergency and procedures the plans, policies and with emergency networks† preparedness and response institution has in place to procedures to prepare for preparedness and response networks prepare for and respond to and respond to a public networks to develop and a public health emergency health emergency 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 Prepares information on the Facilitates the briefing of key Manages implementation of conference calls to receive situation stakeholders to create COOP measures and ICS information† on the situational awareness activation situation
EMR 3.02. ICS activation Performs position Produces information and Confirms staff are available Establishes organization’s ICS responsibilities as assigned documentation for with proper qualifications structure, reporting briefings and capabilities procedures, and chain of command
EMR 3.03. Emergency Locates emergency Uses emergency evacuation Instructs staff during Manages emergency evacuation evacuation routes and routes and assembly areas evacuation evacuation and assembly assembly areas
See table footnotes on page 28.
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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† Recognizes hazardous spills Complies with procedures Instructs staff on proper Manages response to response or potential exposures for responding to response to hazardous hazardous spills or potential hazardous spills or spills or potential exposures potential exposures exposures
EMR 3.05. Emergency Describes emergency Complies with emergency Instructs staff on policies, Manages emergency decontamination† decontamination and decontamination and processes, and procedures decontamination and exposure prevention† exposure prevention for emergency exposure prevention policies, policies and procedures policies and procedures decontamination and processes, and procedures exposure prevention
EMR 3.06. Surge capacity Describes circumstances for, Adjusts workflow§ to ensure Identifies creative strategies Implements a management and varying degrees of timeliness of diagnostic to manage surge or system that promotes surge testing in collaboration overflow testing flexibility and maximizes the with surge partners ability to deliver surge capacity
EMR 3.07. Emergency Describes the emergency Complies with the Ensures rapid and secure Manages the emergency communication plan† communication plan and emergency communication communications with communication plan and the the policies and procedures plan and the policies and emergency response policies, processes, and for receiving and procedures for receiving partners and/or public procedures for securely disseminating information and disseminating during emergencies and receiving and disseminating with emergency response information with surge incidents information with emergency partners and/or public emergency response response partners and the partners and/or public 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 Follows established plans to Implements plans to resume Determines whether staff Manages re-opening and/or recovery resume normal operations normal operations after an and facilities are able to continuation of routine after an emergency event emergency event return to normal operations services after an emergency event
EMR 4.02. After Action Describes the AAR process Participates in AAR process Assists with developing the Oversees the AAR process Review (AAR)† final AAR
EMR 4.03. Long-term Lists improvements to Identifies improvements to Implements improvements Develops recommendations to recovery laboratory plans based on laboratory plans and to laboratory plans and improve laboratory plans and the AAR operations based on the operations based on the operations based on the AAR AAR AAR along with internal and external partners and stakeholders
EMR 4.04. Financial Lists costs relative to Explains costs relative to Determines financial and Verifies financial and staff considerations response and recovery response and recovery staff resources required to resources are in place to activities activities facilitate laboratory’s facilitate laboratory’s response and recovery response and recovery
EMR 4.05. Legal and Describes legal and Implements legal and Assesses staff compliance Oversees staff compliance with regulatory issues regulatory requirements for regulatory requirements for with legal and regulatory legal and regulatory managing emergency managing emergency requirements related to the requirements related to the events events managing of emergency managing of emergency events 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.
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Workforce Training Competency knowledge to carry out their responsibilities in all aspects of their job performance. This domain provides guidance to staff Guidelines members on subject matter expertise and project management Purpose statement: The competencies in Workforce for the development and delivery of training. Training address the knowledge, skills, and abilities needed As persons are an organization’s most valuable asset, having to train public health laboratory professionals (Table 7). well-trained staff members at all functional levels improves This includes the design, development, implementation, and organizational performance and ensures the success of the evaluation of all types of training. laboratory in providing services to address public health concerns. Introduction: Workforce Training is a process that uses Notes: Sources were identified as support documents for principles of adult learning and instructional design to develop, this domain (36,58). This domain is intended for the general manage, deliver, and evaluate internal and outreach education laboratory scientist and not solely for education or training and training activities. Although training services and resources specialists or subject matter experts. The competencies apply can be accessed externally, management should also support to all types of training modalities. internal activities to ensure staff members possess the skills and
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 Conducts needs assessments Develops needs assessment Prioritizes training needs activities tools based on needs assessments
WFT 1.02. Adult learning Explains adult learning Selects principles and Integrates principles of adult Ensures that adult learning methodologies methodologies methodologies which learning for use in designing principles are applied in underpin adult learning training designing training
WFT 1.03. Subject matter Employs subject matter Implements established Develops emerging science Collaborates with national expertise knowledge in order to train science and technology and technology content and international scientific entry-level staff content communities to create new knowledge on subject matters
WFT 1.04. Training topics Researches emerging training Implements training for Designs training for emerging Identifies emerging training topics emerging training topics training topics topics with national and international scientific communities
WFT 1.05. Incorporation of Explains requirements* for Collaborates with subject Develops new processes* to Identifies emerging processes subject matter expertise the use of subject matter matter experts to gather capture subject matter to capture subject matter into training activities experts content expertise expertise
WFT 2.00. Training design: designs training Subcompetency Beginner Competent Proficient Expert WFT 2.01. Instructional Explains instructional design Recognizes the instructional Applies instructional design Evaluates instructional design design* principles design principles in existing principles to develop a new and training modalities* training activities training activity throughout the entire menu of training for the organization
WFT 2.02. Learning objectives Explains learning objective Develops training activities Creates learning objectives Evaluates whether learning concepts and training around existing learning for new training activities objectives were written activities objectives following industry guidelines
WFT 2.03. Training modalities Identifies different types of Implements the modality for Selects the modality for the Provides vision and guidance training modalities training training for training modalities
See table footnotes on page 31.
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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 Applies cultural awareness Evaluates the incorporation Ensures incorporation of and its importance as it principles when designing of cultural awareness cultural awareness relates to developing training activities principles into training principles into training training activities activities activities
WFT 2.05. Instructional Assembles instructional Prepares instructional Develops instructional Incorporates industry-wide materials preparation materials materials for existing materials for new programs instructional materials into programs that are aligned with the the training program type of training activity and modality
WFT 2.06. Training materials Uses pre-existing training Integrates multiple types of Develops training materials Evaluates training materials application materials to design simple training materials into from industry resources from industry resources training training design
WFT 2.07. Training exercises Delivers exercises within a Integrates individual training Evaluates training exercises Designs integrated training training session lessons, including exercises with partners experiential exercises
WFT 2.08. Formative Explains formative Employs formative Creates formative Evaluates effectiveness of assessment* assessment assessments assessments formative assessments
WFT 2.09. Continuing Explains the requirements of Follows continuing education Selects continuing education Oversees the continuing education the continuing education provider requirements provider for new learning education provider process provider when conducting training activities
WFT 3.00. Delivery set-up: manages the logistics of set-up for training delivery Subcompetency Beginner Competent Proficient Expert WFT 3.01. Equipment Operates equipment needed Troubleshoots training Ensures that equipment Oversees processes for preparation for training to deliver training equipment capability aligns with the upgrading training delivery training requirements equipment
WFT 3.02. eLearning* Tests eLearning courses Creates supporting materials Develops storyboards for Ensures that eLearning or content for storyboards new courses using subject delivery systems are matter expert materials available
WFT 3.03. Learning Provides support for learning Manages processes of the Develops processes to Oversees the processes for environment* environment processes learning environment manage the learning the learning environment environment
WFT 4.00. Training delivery: applies principles of learning to training implementation and delivery Subcompetency Beginner Competent Proficient Expert WFT 4.01. Learning Explains presentation Differentiates presentation Develops presentation Creates strategies to address preferences and styles materials for different materials to address materials to address learning preferences and learning preferences and learning preferences and learning preferences and styles styles styles styles
WFT 4.02. Presentation Explains the most effective Uses the most effective Ensures implementation of Oversees presentation engagement presentation tools and presentation tools and the most effective engagement strategies techniques techniques presentation tools and techniques
See table footnotes on page 31.
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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 Lists the steps the Carries out the evaluation Develops training evaluation Oversees the evaluation of process* organization undertakes for steps for standard training tools* for a new activity the training process for the training program evaluation evaluations for routine organization courses
WFT 5.02. Delivery of the Contributes to development Implements the training Creates a training assessment Evaluates the training evaluation of a training assessment assessment rubric to ensure rubric to ensure training assessment rubric to ensure rubric* to ensure training training outcomes are met outcomes are met training outcomes are met outcomes are met
WFT 5.03. Training reports* Gathers data as directed for Compiles tracking data into Develops summative training Interprets summative data summative training reports summative training reports reporting tools from reports for delivery to stakeholders
WFT 5.04. Training activity Shares training activity Assesses participants’ Recommends improvements Implements improvements to effectiveness observations with achievement of training based on evaluation data the professional supervisor objectives from training assessment development activities of tools the laboratory
WFT 5.05. Continuous Participates in continuous Identifies activities leading to Facilitates activities leading Develops a training program improvement of the training improvement activities the continuous to the continuous improvement plan based on program improvement of a training improvement of a training program evaluation plan plan
WFT 6.00. Marketing: markets training opportunities Subcompetency Beginner Competent Proficient Expert WFT 6.01. Marketing Participates in the marketing Composes content for Develops organizational Manages the training of training marketing materials marketing plan for training marketing plan
* This term is defined in Appendix B.
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General Laboratory Practice These broad practices are central to the performance of laboratory testing. Laboratory scientists, regardless of their Competency Guidelines specific area of scientific or technical expertise, rely on these skills Purpose statement: The competencies in General to accomplish the array of testing in public health laboratories. Laboratory Practice address the knowledge, skills, and abilities Notes: Sources were identified as support documents for needed to fulfill basic responsibilities for performing sample this domain (59,60), which is intended for both general analyses within a public health laboratory setting (Table 8). and specialized laboratory scientists. This domain is meant Introduction: General laboratory practice is the set of to be used in conjunction with specialized domains such foundational knowledge and capabilities needed for the testing as Microbiology, Chemistry, and Research since it includes of samples across the wide spectrum of scientific and technical technical practices not addressed in those domains. The activities of public health laboratories. As these practices can be verb “oversees” is used extensively in the Expert level. In this applied in many areas of analysis, they have been consolidated context, “oversees” is a broad term that comprises the many into this domain to minimize, but not eliminate, repetition functions related to the management of policies, processes and across the specialized domains and to create a domain that procedures to include creation, design, development, directing, covers testing not specifically encompassed by the Chemistry monitoring, evaluation, and collaboration. or Microbiology domains.
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 Applies basic scientific and Instructs others in concepts Ensures that accepted Oversees that laboratory and laboratory concepts and laboratory concepts and and theories related to the concepts and theories are practices are in accordance theories theories* related to the specific testing that is applied to laboratory testing with accepted scientific and specific testing that is conducted in work area laboratory concepts and conducted in work area theories
GEN 1.02. Mathematical and Applies fundamental Instructs others in Ensures appropriate Oversees the policies,* statistical concepts and mathematical and statistical fundamental mathematical utilization of mathematical processes,* and procedures* practices concepts and practices in and statistical concepts and and statistical concepts and regarding the use of work area practices practices mathematical and statistical concepts and practices
GEN 1.03. Scientific and Reads scientific and technical Discusses scientific and Integrates scientific and Critiques scientific and technological advances literature relevant to own technical advances relevant technical advances into technological advances to work to own work laboratory operations evaluate possible impact for the laboratory
GEN 1.04. Technical skills Applies basic laboratory Integrates basic laboratory Ensures that staff are properly Oversees the application of techniques to laboratory techniques into standard trained in the performance technical skills to laboratory testing operating procedures* and of technical skills practices new laboratory practices
GEN 1.05. Troubleshooting Identifies routine problems Resolves routine technical Resolves complex technical Oversees the policies, related to technical duties problems with methods, problems with methods, processes, and procedures and responsibilities procedures, and laboratory procedures, and laboratory related to troubleshooting equipment,* including equipment, including technical problems documenting corrective documenting corrective action action
GEN 1.06. Model laboratory Applies knowledge of model Instructs others in model Implements model laboratory Manages policies, processes, practices* laboratory practices laboratory practices practices and procedures to ensure staff comply with model laboratory practices
See table footnotes on page 35.
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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 Instructs others in use of Ensures utilization of Oversees the policies, results using established paper or electronic methods established paper and processes, and procedures paper or electronic systems or systems for electronic documentation for the creation and use of documentation methods or systems paper and electronic methods or systems for documentation
GEN 1.08. Stewardship of Acts as a good steward of Identifies methods to Ensures that the use of public Oversees the policies, resources public funds and resources improve stewardship of funds and resources meet processes, and procedures resources the policies for stewardship to ensure the environment supports effective stewardship of resources
GEN 1.09. Scientific ethics* Applies scientific ethics and Serves as a role model, Ensures staff compliance with Oversees the policies, rules of conduct to the consistently conforming to the policies and procedures processes, and procedures workplace the highest scientific related to scientific ethics related to scientific ethics standards and practices and rules of conduct 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 Adheres to policies, Instructs staff in use and Ensures staff compliance with Oversees the use and storage reagents and supplies processes, and procedures storage of reagents and policies, processes, and of reagents and supplies for use and storage of supplies procedures for use and reagents and supplies storage of reagents and supplies
GEN 2.02. Reagent Adheres to policies, Instructs staff in preparing Ensures staff compliance with Oversees the policies, preparation processes, and procedures reagents policies, processes, and processes, and procedures for preparing reagents procedures for reagent for reagent preparation 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 Adheres to policies, Instructs staff in the operation Ensures staff compliance with Oversees the policies, operation processes, and procedures of laboratory equipment policies, processes, and processes, and procedures for operating laboratory procedures for the operation for the operation of equipment of laboratory equipment laboratory equipment
GEN 3.02. Equipment Performs routine system Instructs staff in procedures Determines need for repair or Oversees the policies, maintenance checks and maintenance to ensure equipment replacement of laboratory processes, and procedures function equipment for the maintenance, repair, and replacement of laboratory equipment
GEN 3.03. Instrument and Performs calibration of Performs calibration of Develops processes and Oversees the policies, equipment calibration routine instruments and complex instruments and procedures for calibration of processes, and procedures equipment equipment instruments and equipment for calibration of instruments and equipment
GEN 3.04. Preventive Documents maintenance and Inspects preventive Evaluates the preventive Oversees the preventive maintenance and calibration calibration activities maintenance and maintenance and calibration maintenance and calibration records* calibrations records for records program completeness See table footnotes on page 35.
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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 Follows policies, processes, Instructs others in policies, Monitors staff compliance Oversees sample management* and procedures for the processes, and procedures with established sample management policies, management of samples* for sample management management policies, processes, and procedures 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 Ensures staff compliance with Oversees the policies, analyses policies, processes, and processes, and procedures procedures for sample related to sample analyses analyses
GEN 5.02.Testing workflow† Adheres to policies, Instructs staff in policies, Ensures staff compliance in Oversees the policies, processes, and procedures processes, and procedures following established processes and procedures for testing workflow regarding testing workflow testing workflow that optimize and improve testing workflow
GEN 5.03. Quality control Performs QC activities Interprets QC data prior to Examines QC data over time Oversees the policies, (QC)* analysis reporting results to establish QC ranges and processes, and procedures limits 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 Evaluates QC data for a given Ensures staff compliance with Oversees the policies, evaluation data reporting period established policies, processes, and procedures processes, and procedures related to QC evaluation for QC evaluation activities activities
GEN 6.02. Test analysis and Assembles test data for Analyzes test data Interprets complex or Oversees the policies, results interpretation review and action ambiguous results processes, procedures, and algorithms related to data analysis and results interpretation
GEN 6.03. Results reporting Adheres to policies, Instructs staff in the policies, Ensures staff compliance with Oversees the policies, and data release processes, and procedures processes, and procedures policies, processes, and processes, and procedures related to reporting and related to reporting and procedures related to related to reporting and release of examination release of examination reporting and release of release of examination results and notifiable results and notifiable results examination results and results and notifiable results results* notifiable results to partners
GEN 6.04. Turnaround time Performs laboratory testing Monitors TAT performance Identifies process efficiencies Oversees the policies, (TAT ) and reporting within to improve TAT processes, and procedures specified or expected TAT related to TAT
GEN 6.05. Quality assurance Explains the differences Collects data for reporting on Evaluates QA indicator data Oversees the policies, (QA)* between QA and QC QA indicators and processes processes, and procedures related to QA
See table footnotes on page 35.
34 MMWR / May 15, 2015 / Vol. 64 / No. 1 Supplement
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 Complies with regulatory Instructs staff on regulatory Ensures staff compliance with Oversees the policies, compliance requirements* and requirements and guidelines regulatory requirements and processes, and procedures guidelines related to related to laboratory testing guidelines related to regarding regulatory laboratory testing laboratory testing requirements and guidelines related to laboratory testing
GEN 7.02. Proficiency testing* Performs PT and alternative Reviews PT and alternative Monitors to ensure the PT Oversees the policies, (PT) and alternative assessment assessment results and alternative assessment processes, and procedures assessment* program meets regulatory related to PT and alternative requirements assessments
GEN 7.03. Proficiency testing Reports PT and alternative Reviews submissions of PT Ensures staff compliance with Oversees the policies, (PT) and alternative assessment and alternative assessment reporting of PT and processes, and procedures assessment reporting results alternative assessment related to PT and alternative results assessment reporting
GEN 7.04. Method validation* Participates in performance Compiles results of method Evaluates method validation Oversees the policies, and performance of method validation and validation and performance and performance processes, and procedures verification* performance verification verification verification results related to method validation and performance verification
GEN 7.05. Protected Complies with policies, Instructs staff in policies, Ensures staff compliance with Oversees that organizational information* processes, and procedures processes, and procedures policies, processes, and policies, processes, and regarding protected regarding protected procedures regarding procedures related to information information protected information 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.
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Safety Competency Guidelines actual and potential situations which might place staff members and others at risk, openly assesses those risks, and implements Purpose statement: The competencies in Safety address redundant systems to keep risk to the absolute minimum. It the knowledge, skills, and abilities necessary to ensure a is essential that leadership and management staff members safe working environment that meets or exceeds applicable ensure a comprehensive safety culture for those working in regulatory requirements and guidelines (Table 9). the public health laboratory. This domain comprises five subdomains: A safety culture is fundamental to ensuring the protection • Potential Hazards, which addresses the knowledge, skills, of the laboratory facility, its staff, and the surrounding and abilities needed to recognize potential hazards within environment from hazards and risks related to laboratory a given laboratory setting; operations and services. Safety is the background against • Hazard Control, which addresses the knowledge, skills, which all staff members must perform all aspects of their and abilities needed to support and maintain a health and job. A culture of safety recognizes that to err is human, and safety management system to control or prevent workplace establishes procedures and processes to minimize errors and hazards; avoid harm. To be effective, all staff members are expected to • Administrative Controls, which addresses the knowledge, be part of the culture of safety. skills, and abilities needed to develop a laboratory safety This domain is based on the 2011 ”Guidelines for Biosafety program that is compliant with regulatory, accreditation, Laboratory Competency” (26), with the content revised and and licensing requirements; restructured to fit within this comprehensive set of public • Communication and Training, which addresses the health laboratory competencies. This domain supplements knowledge, skills, and abilities needed to ensure staff and expands upon the 2011 Guidelines. Some reformulation members are informed of all safety hazards through of concepts from the former “Midlevel” and “Senior level” tiers effective communication and the provision of related were introduced here to ensure a wider breadth of bench-level education and training; and and managerial responsibilities. However, the 2011 Biosafety • Documents and Records, which addresses the knowledge, Laboratory Competencies include critical task-level details that skills, and abilities needed to document activities related could not be captured here due to the directives for competency to safety policies, processes, and procedures. development that were adopted. The 2011 Guidelines are, Introduction: Safety focuses on the occupational and therefore, an important companion to this domain. personal safety of staff members and the environments in Note: Multiple sources were identified as support documents which they work. A culture of safety encourages reporting of for this domain (26,51,52,61–74).
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 Describes the physical Recognizes new physical Assesses staff knowledge of Evaluates the laboratory the laboratory facility hazards in the laboratory hazards in the laboratory the physical hazards in the facility for physical hazards facility facility laboratory facility
SPH 1.02. Control measures* Describes control measures Implements control measures Ensures staff knowledge of Establishes the control to be used when physical to be used when physical to be used when physical control measures to be used measures to be used when hazards are present hazards are present in the hazards are present in the when physical hazards are physical hazards are present laboratory facility laboratory facility present in the laboratory in the laboratory facility facility
SPH 1.03. Work practices* to Describes work practices to Implements work practices to Ensures that staff implement Establishes the work be used when physical be used when physical be used when physical the established work practices to be used when hazards are present hazards are present in the hazards are present in the practices when physical physical hazards are present laboratory facility laboratory facility hazards are present in the in the laboratory facility laboratory facility
See table footnotes on page 44.
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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 Lists the biological materials Distinguishes biohazardous Manages the inventory of Establishes the policies,* used in the laboratory in the laboratory materials* from biological materials to processes,* and procedures* nonbiohazardous materials ensure it is complete and for implementing a in the laboratory updated biological materials inventory system
SPH 2.02. Hazards associated Describes hazards associated Recognizes hazards Assesses staff knowledge of Ensures that staff are skilled with the biological materials with the biological materials associated with new the hazards associated with in describing and handled in the laboratory handled in the laboratory biological materials used in biological materials used in recognizing hazards laboratory procedures laboratory procedures associated with the biological materials used in the laboratory
SPH 2.03. Control measures Describes the control Implements the control Ensures that staff implement Establishes the control to be used when working measures to be used when measures to be used when the established control measures to be used when with biological materials working with biological working with biological measures when working working with biological materials materials with biological materials materials
SPH 2.04. Work practices to Describes the work practices Implements the work Ensures that staff implement Establishes the work be used when working with to be used when working practices to be used when the established work practices to be used when biological materials with biological materials working with biological practices when working working with biological materials with biological materials materials
SPH 2.05. Hazards associated Describes hazards associated Trains staff in the hazards Manages the hazards Ensures that staff are capable with laboratory procedures with the laboratory associated with the associated with laboratory of recognizing, training, and procedures employed laboratory procedures procedures managing the hazards employed associated with laboratory procedures
SPH 3.00. Research animals:* works safely with research animals Subcompetency Beginner Competent Proficient Expert SPH 3.01. Hazards associated Describes hazards associated Identifies hazards associated Assesses staff knowledge of Ensures that staff are skilled with research animals with working with research with the particular species the hazards associated with in describing and animals of animals used in the the particular species of recognizing hazards laboratory’s research animals used in the associated with the research laboratory’s research animals used in the laboratory’s research
SPH 3.02. Route of exposure* Describes possible route(s) of Identifies the possible Assesses staff knowledge of Evaluates possible route(s) of to infectious agents in the exposure to infectious route(s) of exposure to the hazards associated with exposure to infectious animal care setting agents in relation to animal infectious agents in relation the animal procedures used agents in relation to the procedures to the animal procedures in the laboratory or animal animal procedures used in used in the laboratory or facility the laboratory and animal animal facility facilities
SPH 3.03. Control measures Describes control measures Implements control measures Ensures that staff implement Establishes the control to be used when working to be used when working to be used when working the established control measures to be used when with research animals with research animals with research animals measures when working working with research with research animals animals
SPH 3.04. Work practices to Describes work practices to Implements work practices to Ensures that staff implement Establishes the work be used when working with be used when working with be used when working with the established work practices to be used when research animals research animals research animals practices when working working with research with research animals animals
See table footnotes on page 44.
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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 Identifies chemicals used in Distinguishes hazardous Manages the chemical Establishes the policies, the laboratory the laboratory chemicals* from inventory to ensure it is processes, and procedures nonhazardous chemicals in complete and updated for implementing a the laboratory chemical inventory system
SPH 4.02. Hazards associated Describes hazards associated Recognizes hazards Assesses staff knowledge of Ensures that staff are skilled with chemicals used in the with chemicals used in the associated with new the hazards associated with in describing and laboratory laboratory chemicals used in the chemicals used in the recognizing hazards laboratory laboratory associated with chemicals used in the laboratory
SPH 4.03. Control measures Describes control measures Implements established Ensures that staff implement Establishes the laboratory’s to be used when working to be used when working control measures when the established control Chemical Hygiene Plan, with chemicals in the with chemicals as working with chemicals measures when working including specific control laboratory documented in the according to the with chemicals in measures to be used when laboratory’s Chemical laboratory’s Chemical compliance with the working with chemicals Hygiene Plan* Hygiene Plan laboratory’s Chemical Hygiene Plan
SPH 4.04. Work practices to Describes the work practices Implements established work Ensures that staff implement Establishes the laboratory’s be used when working with to be used when working practices when working established work practices Chemical Hygiene Plan, chemicals in the laboratory with chemicals as with chemicals according to when working with including specific work documented in the the laboratory’s Chemical chemicals in compliance practices to be used when laboratory’s Chemical Hygiene Plan with the laboratory’s working with chemicals Hygiene Plan Chemical Hygiene Plan
SPH 5.00. Radiological materials:* works safely with radiological materials in the laboratory Subcompetency Beginner Competent Proficient Expert SPH 5.01. Radiological Lists the radiological Describes the characteristics Manages the inventory of Establishes the policies, materials used in the materials used in the of the radiological materials radiological materials to processes, and procedures laboratory laboratory used in the laboratory ensure it is complete and for implementing a updated radiological materials inventory system
SPH 5.02. Hazards associated Describes the hazards Recognizes hazards Assesses staff knowledge of Ensures that staff are skilled with the use of radiological associated with radiological associated with new the hazards associated with in describing and materials materials used in the radiological materials used radiological materials used recognizing the hazards laboratory in the laboratory in the laboratory associated with radiological materials used in the laboratory
SPH 5.03. Control measures Recognizes control measures Implements control measures Ensures that staff implement Establishes, in collaboration to be used when working to be used when working to be used when working established control with radiation safety staff, with radiological materials with radiological materials with radiological materials measures when working the control measures to be in the laboratory in the laboratory with radiological materials used when working with in the laboratory radiological materials in the laboratory
SPH 5.04. Work practices to Describes work practices to Implements work practices to Ensures that staff implement Establishes, in collaboration be used when working with be used when working with be used when working with established work practices with radiation safety staff, radiological materials radiological materials in the radiological materials in the when working with the work practices to be laboratory laboratory radiological materials in the used when working with laboratory radiological materials in the laboratory
SPH 5.05. Radiation Describes monitoring devices Demonstrates operation and Ensures the operation and Evaluates use and suitability monitoring devices* for the radiological use of monitoring devices use by staff of radiation of monitoring devices for materials used in the for the radiological monitoring devices the radiological materials laboratory materials used in the used in the laboratory laboratory
See table footnotes on page 44.
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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 Describes engineering Employs engineering controls Develops standard operating Ensures the implementation controls controls to eliminate or reduce procedures (SOPs)* and of policies, processes, and targeted laboratory hazards work instructions that procedures related to incorporate engineering engineering control design, controls creation, and use
SHC 1.02. Training on Completes required training Trains staff on engineering Develops required training Ensures that training is engineering controls before using engineering controls for engineering controls adequate and appropriate controls for the engineering controls used in the laboratory
SHC 1.03. Function Describes function Performs function Manages the procedures for Develops policies, processes, verification* and verification, maintenance, verification, maintenance, function verification, and procedures to ensure maintenance of engineering and troubleshooting and troubleshooting maintenance, and function verification, controls procedures for engineering processes and procedures troubleshooting for maintenance, and controls for engineering controls engineering controls troubleshooting for engineering controls
SHC 1.04. Malfunction of Recognizes when Implements procedures to Manages processes and Develops policies, processes, engineering controls engineering controls are address and report when procedures for addressing and procedures for compromised, engineering controls are and reporting situations in remediation and reporting malfunctioning, or compromised, which engineering controls of engineering control nonfunctioning, and the malfunctioning, or are compromised, malfunctions to ensure resulting reporting nonfunctioning malfunctioning, or minimal exposure and requirements* nonfunctioning 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 Describes good Practices good housekeeping Develops processes and Oversees the implementation housekeeping procedures* housekeeping procedures procedures procedures related to the of policies, processes, and establishment and procedures related to good maintenance of good housekeeping housekeeping
SHC 2.02. Personal hygiene Describes personal hygiene Complies with personal Develops personal hygiene Ensures staff adherence to procedures* procedures hygiene procedures procedures personal hygiene policies, processes, and procedures
SHC 2.03. Safety practices Describes proper work Uses proper work practices Develops proper work Ensures staff knowledge and and procedures practices and procedures and procedures practices and procedures use of proper work practices and procedures
SHC 2.04. Work schedules Describes how adherence to Monitors staff adherence to Implements procedures to Designs processes and own scheduled work established work schedules ensure scheduling of work procedures to ensure activities and tasks and assigned tasks activities and/or workers’ scheduling of work activities minimizes exposure tasks minimize staff and/or workers’ tasks exposure levels minimize staff exposure levels
See table footnotes on page 44.
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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 Selects appropriate PPE for Develops procedures for the Ensures staff knowledge of and its limitations for jobs jobs assigned appropriate selection of PPE procedures for the assigned appropriate selection of PPE
SHC 3.02. PPE use Describes specific PPE and its Uses specific PPE for each Determines procedures for Ensures staff compliance with limitations for use with each laboratory procedure use of specific PPE procedures for use of laboratory procedure specific PPE
SHC 3.03. PPE inspection Describes pre-and Implements pre-and Develops pre-and Ensures staff knowledge of postinspection procedures postinspection procedures postinspection procedures pre-and postinspection for PPE for PPE for PPE 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, Describes the procedures for Implements procedures for Develops procedures to Ensures staff compliance with tracking, and investigation reporting hazardous reporting and tracking all report, track and investigate reporting, tracking, and conditions hazards hazards in their workspace 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 Performs required preventive Complies with processes and Implements the processes Develops the policies, maintenance maintenance functions procedures to ensure and procedures to ensure processes, and procedures equipment continues to equipment continues to to ensure equipment function effectively function effectively continues to function effectively
SHC 5.02. Corrective Describes troubleshooting Complies with processes and Implements the processes Develops the policies, maintenance methods to determine procedures to ensure and procedures to ensure processes, and procedures whether equipment is equipment repairs equipment repairs to ensure repairs are malfunctioning and the conducted in accordance cause 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 Describes procedures for spill Implements procedures for Manages procedures for spill Develops policies, processes, of laboratory waste cleanup and spill cleanup and cleanup and and procedures for spill decontamination of decontamination of decontamination of cleanup and laboratory waste laboratory waste laboratory waste decontamination of laboratory waste
SHC 6.02. Segregated waste Describes procedures for Implements procedures for Manages procedures for Ensures staff compliance with categorization* and laboratory waste laboratory waste laboratory waste laboratory waste handling categorization and handling categorization and handling categorization and handling categorization and handling policies, processes, and procedures
SHC 6.03. Treatment and Describes procedures for Implements procedures for Manages procedures for Ensures staff compliance with disposal disposal and treatment of disposal and treatment of disposal and treatment of policies, processes, and laboratory waste laboratory waste laboratory waste procedures for disposal and treatment of laboratory waste
See table footnotes on page 44.
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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 Implements procedures for Manages procedures for Ensures staff compliance with laboratory waste reduction laboratory waste reduction laboratory waste reduction policies, processes, and procedures for laboratory waste reduction
SHC 6.05. Regulated waste* Describes procedures for Implements procedures for Manages procedures for Ensures staff compliance with access preventing public access to preventing public access to preventing public access to policies, processes, and regulated waste regulated waste regulated waste procedures for preventing public access to regulated waste
SHC 6.06. Waste management Describes procedures for Implements procedures for Develops procedures to Ensures staff compliance with issues and problems reporting and responding reporting and responding ensure that issues or policies, processes, and to issues or problems to issues or problems problems regarding procedures to address regarding laboratory waste regarding laboratory waste laboratory waste laboratory waste management management management are reported management issues or and addressed problems
SHC 6.07. Monitoring and Describes procedures for Implements procedures for Develops procedures for Ensures staff compliance with evaluation monitoring the laboratory monitoring the laboratory monitoring the laboratory policies, processes, and waste management plan waste management plan waste management plan 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 Ensures staff compliance with Implements the safety Ensures that comprehensive program requirements for safety program program and related safety policies, processes, the jobs performed requirements training programs and procedures are developed as part of the safety program
SAC 1.02. Program audits Participates in audits of the Conducts audits of the safety Designs safety program Evaluates the safety program safety program program audits audit results to identify problem areas
SAC 1.03. Safety inspections Explains the importance of Participates in safety Conducts safety inspections Ensures staff compliance with safety inspections inspections safety inspections
SAC 1.04. Program evaluation Provides feedback on the Collects data relating to the Prepares evaluation reports Designs evaluation reports safety program effectiveness of the safety for the safety program for the safety program program
SAC 2.00. Guideline and regulation compliance: ensures staff compliance with guidelines and regulations Subcompetency Beginner Competent Proficient Expert SAC 2.01. Regulatory Describes current regulatory Complies with current Instructs staff on current Ensures staff compliance with requirements and requirements and regulatory requirements regulatory requirements current regulatory guidelines guidelines governing the and guidelines governing and guidelines governing requirements and safe performance of the safe performance of the safe performance of guidelines governing the laboratory procedures laboratory procedures laboratory procedures safe performance of laboratory procedures
SAC 2.02. Institutional safety Describes institutional safety Complies with institutional Participates in a leadership Ensures staff compliance with committees* committees safety committee role on institutional safety institutional safety requirements committees committee requirements
See table footnotes on page 44.
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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 Implements control measures Manages the risk assessment Oversees the policies, process identified in risk process processes, and procedures assessments 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, Reviews reports of incidents Conducts routine monitoring Designs policies, processes, including near-misses to identify root causes and of staff compliance and procedures for problems regarding incident reporting and performing reporting 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 Describes the organization’s Identifies staff eligible to Monitors staff compliance Designs the vaccination program vaccination program participate in the with the vaccination program based on exposure vaccination program program risks and regulatory requirements
SAC 4.02. Medical Describes the organization’s Identifies staff eligible to Monitors staff compliance Designs the medical surveillance program* medical surveillance participate in the medical with the medical surveillance program based program surveillance program surveillance program on risks encountered and regulatory requirements
SAC 4.03. Exposure Describes exposure Complies with exposure Ensures staff compliance with Develops the exposure monitoring* monitoring procedures monitoring procedures exposure monitoring monitoring policies and policies and processes processes based on risks encountered and regulatory requirements
SAC 4.04. Occupational Identifies the process to Complies with organizational Prepares summary of Develops occupational incidents obtain medical services requirements and occupational incidents incident response plan* after an occupational healthcare provider including regular review incident treatment plans pertaining and revisions following an to an occupational incident 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 Adheres to information and Evaluates safety signage and Ensures staff compliance with documentation as well as directives in safety signage document placement and safety signage and how signage is used to and documents* usage documents convey information
SCT 1.02. Safety Describes a variety of Employs a variety of Implements a variety of Ensures a variety of communication tools communication tools and communication tools and communication tools and communication tools and techniques promoting the techniques promoting the techniques for the techniques promoting work work practices employed in work practices employed in promotion of safe work practices are employed in own area of responsibility own area of responsibility practices their area of responsibility
See table footnotes on page 44.
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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 Adheres to procedures for Implements procedures to Ensures staff compliance with samples* and containers labeling of samples and ensure staff compliance regulatory requirements for containers with regulatory labeling of samples and requirements for labeling of containers samples and containers
SCT 1.04. Signals and alarms Recognizes signals and Explains signals and alarms in Assesses staff knowledge of Ensures the implementation alarms in areas assigned the laboratory facility signals and alarms 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 Provides training on the work Assesses safety training Ensures development and to obtain safety training practices and techniques needs and the impact of implementation of safety required for staff to safely safety training training for all staff perform their job duties
SCT 2.02. Training Describes requirements for Adheres to procedures for Implements procedures for Develops policies, processes, documentation documenting safety training recording safety training of documenting staff safety and procedures for staff training 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 Describes procedures for Adheres to procedures for Manages safety document Designs the safety document management safety document safety document management process management system management management
SDR 1.02. Safety document Identifies any restricted or Ensures restricted or Implements processes and Designs policies, processes, access confidential safety confidential safety procedures for maintaining and procedures for documents documents are not confidentiality* of internally document control and disclosed and externally derived access that adhere to safety information regulatory and accreditation requirements
SDR 1.03. Occupational Describes responsibilities for Complies with Ensures staff compliance with Designs policies, processes, injuries and illnesses documenting Occupational documentation procedures reporting of OSHA- and procedures to ensure documentation Safety and Health for OSHA-recordable recordable occupational reporting for OSHA- Administration (OSHA)* occupational injuries and injuries and illnesses recordable occupational recordable occupational illnesses injuries and illnesses injuries and illnesses
SDR 1.04. Medical Describes responsibilities in Complies with established Implements processes and Designs policies, processes, surveillance documentation complying with established medical surveillance procedures for medical and procedures for medical medical surveillance documentation and surveillance documentation surveillance documentation recordkeeping procedures recordkeeping procedures
See table footnotes on page 44.
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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 Describes the procedures for Adheres to procedures for Implements procedures for Designs policies, processes, monitoring documentation documenting exposure documenting exposure documentation and and procedures for monitoring monitoring retention of exposure documentation and monitoring information as retention of exposure required by regulations monitoring information as required by regulations
SDR 1.06. Safety inspection Describes safety inspection Complies with procedures for Develops procedures for Designs policies, processes, documentation documentation safety inspection safety inspection and procedures for safety documentation documentation inspection documentation
SDR 1.07. Hazardous waste Describes procedures for Complies with procedures for Develops procedures for Ensures staff compliance with documentation documenting the handling documenting the handling documenting the handling policies, processes, and and transport of hazardous and transport of hazardous and transport of hazardous procedures for waste waste waste documenting the handling and transport of hazardous waste
SDR 1.08. Safety reports to Reads safety reports Complies with Ensures staff compliance to Designs policies, processes, staff members recommendations and recommendations and and procedures ensuring mandates of safety reports mandates made in safety staff compliance to reports 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.
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Surveillance Competency Guidelines laboratory-generated results are crucial to target public health prevention and ensure the health of communities. Public Purpose statement: The competencies in Surveillance health laboratory scientists and epidemiologists need to work address the knowledge, skills, and abilities required for the closely to ensure effective population-based disease control and collection and analysis of data to support public health decision prevention. Effective laboratory reporting to epidemiologists, making to ensure the health of the community (Table 10). This providers, or other submitters also requires an electronic includes continuous laboratory testing, data compilation, and laboratory reporting (ELR) system that is interoperable with data dissemination on infectious organisms, chemical analytes, electronic health records and notifiable condition reporting radiological materials, and evidence of hereditary anomalies. for both care and surveillance. Introduction: Surveillance is the continuous, systematic The public health laboratory plays a unique role in public collection, analysis, and interpretation of health-related data health surveillance by providing crucial information on the needed for the planning, implementation, and evaluation of appropriate samples and testing methods, by identifying 75 public health practice ( ). With surveillance, the spread of harmful substances and agents, and by providing the ability disease (i.e., any condition that causes injuries, disabilities, to investigate and communicate unusual findings. It is disorders, syndromes, infections, or symptoms) is monitored essential for laboratory staff members to understand both their to establish patterns of progression to predict, observe, and individual role and the laboratory’s role in surveillance, testing, minimize the harm caused by the disease. Well-developed reporting, and disease and exposure monitoring. surveillance capacity is the foundation on which health Notes: Multiple sources were identified as support departments detect, evaluate, and design effective responses documents for this domain (15,75–77). Because all public to public health threats. Laboratory information and services health laboratory testing has a direct or indirect impact on are essential to public health surveillance, as the collection, surveillance, this domain is intended for all staff members and validation, analysis, interpretation, dissemination, and use of not just for persons involved in dedicated surveillance activities.
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 Describes the importance of Explains the integration of Ensures selected laboratory Oversees the policies,* laboratory surveillance public health laboratory public health laboratory testing and reporting processes,* and procedures surveillance testing testing into broader procedures* are aligned that ensure laboratory data surveillance programs with surveillance activities will support public health and program requirements* 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 Reports data to laboratory Manages the approval and Contributes to determination and regulations management communication of public of national, state, and local health surveillance test notification conditions results
SRV 3.00. Surveillance testing: performs surveillance testing Subcompetency Beginner Competent Proficient Expert SRV 3.01. Surveillance testing Describes test sample* Identifies the functional Creates surveillance testing Directs development and systems collection, storage, and requirements of surveillance protocols that include modifications to analytical requirements testing protocols† functional requirements surveillance testing systems based on jurisdictional guidance and analytical capabilities
See table footnotes on page 48.
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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 Describes test sample Employs established testing Customizes testing workflow Directs development and workflow§ collection, storage, and workflow and test methods policies and procedures to modifications to analytical method for the surveillance target the surveillance target surveillance testing system workflows requirements requirements workflows
SRV 3.03. Surveillance testing Tests samples for surveillance Participates in performance Applies technical knowledge Oversees the selection and evaluation of surveillance to develop test methods creation of public health test methods and testing and testing capabilities surveillance tests capabilities used in surveillance
SRV 3.04. Outbreak* or Describes at least one Informs supervisor of Reports potential outbreak or Contributes to the exposure event* detection definition of an outbreak or potential outbreak or exposure events to key modification of outbreak or exposure event exposure event stakeholders exposure event recognition processes or definitions
SRV 3.05. Sample collection Receives outbreak or Ensures that outbreak or Collaborates with key Contributes to sample for outbreak or exposure exposure event samples for exposure event samples stakeholders to determine collection guidelines for events testing meet sample collection the best samples to collect outbreak or exposure event criteria scenarios
SRV 3.06. Testing for outbreak Follows sample prioritization Ensures that outbreak or Reports outbreak or exposure Represents the laboratory in or exposure events schema for testing during exposure event samples are event testing results to key After Action Reviews* for an outbreak or exposure prioritized according to stakeholders outbreak or exposure event schema events
SRV 4.00. Response to critical surveillance event:* responds to critical surveillance events Subcompetency Beginner Competent Proficient Expert SRV 4.01. Critical event Describes critical event Applies critical event Evaluates plans and After Modifies the policies, planning response processes and processes and procedures Action Review findings processes, and procedures procedures related to related to surveillance following critical events for critical surveillance surveillance events based on results of exercises or actual events
SRV 4.02. Critical event Describes own critical event Manages resources required Implements the critical event Oversees the activation and response response duties related to to respond to critical events response plan termination of the critical surveillance event response plan
SRV 4.03. Coordination of Describes the need to Communicates testing Coordinates testing activities Ensures implementation of response coordinate testing priorities priorities to staff and during critical events to response plans during laboratory management align with identified testing critical events priorities
SRV 4.04. New testing Identifies when current Applies technical knowledge Develops plans to address Determines the overall capabilities testing capabilities do not to implement new testing testing capabilities for a strategy for development of exist to test an analyte or capabilities specific new organism or new testing capabilities organism analyte during critical during critical surveillance surveillance events events
See table footnotes on page 48.
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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 Enters demographic Communicates the required Ensures submission of crucial Determines demographic information information that is demographic information to demographic information information fields required necessary to carry out submitters by submitters in informatics systems, surveillance testing requisition forms, and activities reports
SRV 5.02. Sample information Enters sample information Monitors the capture of Ensures collection of sample Determines policies, that is necessary to carry sample information information processes, and procedures out surveillance testing for sample information activities 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 Analyses laboratory Interprets laboratory Develops standards for data analysis methods surveillance data surveillance 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 Ensures data collection Coordinates modifications to reliability of data collection system adheres to data collection systems instruments and methods laboratory, local, and using state and national national standards guidance and methods
SRV 7.02. Data storage and Uses secure and stable data Ensures that the design of Develops secure and stable Develops standards for retrieval storage and retrieval storage and retrieval data storage and retrieval secure and stable data systems databases include the systems, including creating storage and retrieval necessary variables and new variables as necessary data dictionary to support analysis of data
SRV 8.00. Recognition of significant results: recognizes significant results in surveillance data Subcompetency Beginner Competent Proficient Expert SRV 8.01. Significant values Adheres to policies and Reports significant results Monitors significant results to Develops plans with and results procedures to verify with interpretation to ensure staff compliance customers to identify significant results laboratory management with policies for reporting significant results in the and customers* population or environment
SRV 8.02. Trends in data Provides trend results to Identifies trends in Explains trends in Evaluates testing capabilities laboratory management surveillance data surveillance data to based on trend data to laboratory management address customer needs and customers and public health issues
See table footnotes on page 48.
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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 Communicates approved Implements the multi- Manages the multi- Develops a multi-disciplinary teamwork laboratory information to disciplinary surveillance disciplinary surveillance surveillance communication other institutions communication plan communication plan plan
SRV 9.02. Education and Explains sample Guides partners in selection Evaluates effectiveness and Develops surveillance feedback for partners requirements and testing of laboratory methods, data efficiency of surveillance policies, processes, and procedures collection, and evaluation processes and procedures procedures with partners between laboratory and partners
SRV 10.00. Dissemination of data: disseminates data relevant to audience Subcompetency Beginner Competent Proficient Expert SRV 10.01. Presentation of Describes importance and Reports surveillance and Explains surveillance and Synthesizes surveillance and surveillance and monitoring use of oral and written monitoring data orally or in monitoring data orally or in monitoring data orally and data communication in writing to laboratory writing to external in writing for national and presenting surveillance and management and stakeholders international audiences for monitoring data epidemiologists 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.
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Informatics Competency Guidelines laboratory reporting (ELR) system and electronic health record (EHR) system. Since all laboratories must rely on informatics Purpose statement: The competencies in Informatics capabilities and often have limited access to informaticians address the knowledge, skills, and abilities needed to or informatics specialists, it is essential that all staff members systematically apply information science, computer science, maintain varying levels of informatics competencies. and information technology to support public health practice, Notes: Multiple sources were identified as support documents research, and learning (Table 11). for this domain (20,78–81). In particular, the competencies Introduction: Informatics is a broad field encompassing defined in this domain are based on the content and framework information science, information technology, algorithms, of a 2013 comprehensive public health laboratory informatics and social science. In addition to electronic recordkeeping self-assessment tool (78). In turn, this tool was framed on an and automated data management, informatics includes such earlier document (79) outlining consensus on the business activities as test analyses, clinical decision support, messaging, requirements of laboratory information management systems. and knowledge management. Once thought of as a support Some of the competencies provided in these guidelines, function, the delivery of laboratory informatics services has particularly the Expert level, might appear beyond the reach now evolved to be a mission-critical and central component of the typical bench scientist. While laboratory scientists of laboratory operations. might initially have competencies limited to the Beginner or Informatics is critically important to the public health Competent level, a long-term goal is to ensure that public health laboratory’s role in protecting the public from infectious laboratories have within their ranks scientists with competencies diseases, environmental dangers, and other health threats. at the Proficient and Expert levels. This domain includes paper Public health laboratory informatics must be cross-cutting systems as part of the laboratory information system. and interoperable to support a nationally integrated electronic
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 Describes electronic Verifies electronic Evaluates the electronic Designs log-in screens to accessioning modules* used to log in accessioning activities to modules needed for automate sample receiving samples with ensure completeness and sample receiving and and accessioning and to corresponding electronic accuracy accessioning automate processing of requests electronic test request messages
INF 1.02. Electronic data exchange Describes electronic Performs oversight of Manages daily electronic Designs systems to regarding test requests modules used to receive entered data to ensure data exchange activities automate electronic test data on samples using one accurate mapping of client regarding test requests to orders and work processes* or more standard message data to comparable fields ensure efficient operations types* in electronic systems and resolution of root causes of errors
INF 1.03. Vocabulary standards* Lists local codes and Manages use of vocabulary Evaluates use of vocabulary Develops codes for standardized codes standards across parties standards for identification generation of messages of missing or misidentified using multiple standardized codes vocabulary formats and integration of local and new codes and vocabulary standards
INF 1.04. Test orders Describes processes and Verifies the electronic Evaluates the need for new Designs workflows† and procedures* for test orders assignment of tests to test orders and associated modules to automate specific laboratory meta data assignment of test orders programs* to specific laboratory programs
INF 1.05. Hardware to promote Uses basic hardware, Troubleshoots installation Configures a variety of Integrates use of new sample handling efficiency scanners, and robotics and operation of basic complex hardware to technologies for sample automation hardware ensure proper operation accessioning
See table footnotes on page 61.
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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 Verifies the routine entry of Manages problem Designs modules to identifiers and core data metadata and pass- resolution concerning automate the entry of elements through auxiliary data entry of metadata and auxiliary data, the auxiliary data 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 Describes use of predefined Verifies the assignment of Manages prioritization for Designs systems to receipt of samples electronic modules to samples to individual test preparation and handling automate the electronic assign samples or batches* processes or test of samples management of pre- of samples to processes in processing combinations examination* operations the laboratory on samples received individually or in batch
INF 2.02. Electronic test requests Describes how to use Verifies the receipt of Ensures that valid values Designs systems to from submitters electronic modules to samples and associated and test codes are properly automate the electronic manage individual or electronic test requests harmonized between management of test batches of samples from from submitters submitters and receiving requests from submitters submitters laboratory
INF 2.03. LIMS tracking of testing Describes how to use Verifies effectiveness of Evaluates the LIMS tracking Designs systems to processes and associated sample electronic modules to track ongoing sample source of testing processes and automate and manage the sources testing processes and tracking and submitter’s associated sample sources tracking of testing associated sample sources monitoring efforts processes and associated sample sources
INF 2.04. Test results recording Describes electronic Populates test results data Troubleshoots automated Designs analytical sequences modules, vocabulary, and using pre-existing test results data capture for instrument integration usage for specific test modules utilities and data capture utilities to results automate data transfer from instruments
INF 2.05. Data review Describes preparation of Verifies data and results Evaluates the need for new Develops workflows and data summaries that are using predefined progress tracking reports to utilities to ensure that used for review processes reports facilitate data review needed data are supplied
INF 2.06. Data verification Explains test result choices Verifies that the electronic Institutes rules to ensure Designs the processes for that exist for specific test transfer of quality that laboratory programs automating data requests assurance (QA)* and have tools to manage data verification and associating quality control (QC)* data* verification processes QA and QC data with occurs to ensure that test individual sample tests and results meet procedural batches before reporting requirements* and auto-assignment
INF 2.07. Auto-assignment of Describes the electronic Verifies that auto- Evaluates the processes for Develops code for design reflex* or repeat testing processes that define assignment of reflex or auto-assignment of reflex and configuration of auto-assignment of reflex repeat testing is or repeat testing processes for automating or repeat testing performed the assignment of reflex or repeat testing
See table footnotes on page 61.
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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 Describes electronic Verifies analytical data, Appraises solutions for data Constructs queries for ad hoc reports modules used to print data information, and reports selection for nonroutine data searches and information* in reports and for research automated reports purposes
INF 3.02. Report production Describes use of electronic Selects results for reporting Evaluates report production Develops code to query and modules to generate using standardized processes report laboratory data automated and manual predefined report formats reports or test results
INF 3.03. Electronic reporting Sends predefined reports Reports test results using Manages the tracking and Develops reports that contain via electronic reporting predefined electronic needs assessment* of electronic messages for test formats messages that meet electronic reporting of results using agreed-upon agreed-upon standards data standards and vocabulary for message creation and transport
INF 3.04. Management of reports Prints predefined reports Verifies that reports adhere to Modifies noncomplex Develops automated according to policies* submitters’ data exchange electronic formats to meet processes to manage format requirements for customer* requirements reporting of results electronic results submittal and reporting
INF 4.00. Laboratory test scheduling: manages laboratory test scheduling Subcompetency Beginner Competent Proficient Expert INF 4.01. Scheduling documents* Prints existing worksheets, Prioritizes test scheduling to Develops work lists, Develops processes for work lists, and test resolve conflicts and worksheets, and test integration of documents scheduling documents turnaround time scheduling documents to link test orders with test results
INF 4.02. Management of test Enters data to remove or Uses specific data elements Evaluates the workflow for Develops codes to automate schedules restore completed test associated with process process improvement the creation of test status requests improvement to manage opportunities reports and workflows test schedules
INF 4.03. Prioritization of tests Logs in samples according Manages test requests using Organizes specific data Develops systems to to predefined generic laboratory-specified elements associated with electronically generate a priorities criteria process improvement real-time test schedule indicators* to prioritize test scheduling
INF 5.00. Prescheduled testing: manages prescheduled testing Subcompetency Beginner Competent Proficient Expert INF 5.01. Prescheduling Describes electronic Manages scheduling of Troubleshoots electronic Develop automated modules for receipt and single or recurring test systems to preschedule processes to manage the processing of pre- requests tests and to predict and receipt and processing of scheduled samples and kit adjust workload pre-scheduled samples, distribution recurring test requests, and kit distribution
See table footnotes on page 61.
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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 Uses predefined electronic Assigns identifiers to Evaluates automated Develops systems to accessioning modules to enter data samples modules that verify system determine sample tracking relevant to track all steps in operations regarding and location the sample lifecycle* tracking
INF 6.02. Chain of custody Uses predefined modules to Ensures staff compliance Manages electronic tracking Develops systems to track and document with chain of custody data by validating that electronically automate the custody of the sample policies and procedures chain of custody is communication of chain of from receipt to disposal or complete and custody data tracking to return to submitter documented users and submitters
INF 6.03. Chain of custody data Uses predefined modules to Verifies that predefined Evaluates existing and Develops systems to elements link demographic data modules allow creation, future modules for integrate data elements with data on chain of tracking, and maintenance tracking data elements into automated chain of custody, sample of sample and aliquot custody management appropriateness,* sample hierarchy through the handling, and elements of LIMS throughout the sample analyst location, laboratory time, and defined storage parameters
INF 6.04. Tracking samples in Uses predefined modules to Verifies the routine tracking Creates work lists, Develops modules to analytical processes track samples assigned to of aliquots, instrument worksheets, and incorporate factors that laboratory programs sequence numbers, and workgroups to improve affect automated during analytical processes work lists the tracking of samples 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 Verifies the tracking, Determines the availability Designs code or scripts to electronic modules to management, and and cost-effectiveness of automate activities to track, order supplies and control maintenance of inventory in-house manufacturing order, and manage inventory and use of supplies inventory
INF 7.02. Inventory production Performs data entry into Validates the production of Evaluates data to improve Writes code or scripts to existing electronic inventory the current and future automate inventory control modules to document states of inventory production of inventory production
INF 7.03. Manufacturing Accesses manufacturing Maintains the database of Validates manufacturing Develops workflows for formulations formulations electronically manufacturing formulations and SOPs manufacturing formulations formulations
INF 7.04. Supply orders and Enters inventory order data Verifies the use of codes and Manages order frequency Develops workflows to vendors into electronic order parameters necessary to and timetables automate the ordering of systems automate electronic orders supplies from vendors of supplies
See table footnotes on page 61.
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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 Explains data elements and Identifies analytical data Develops automated Configures modules to collection formats necessary for data and results and the interfaces to export data automate the export of collection and exchange exchange of this from instruments to analytical data to electronic information using electronic storage storage predefined modules
INF 8.02. Electronic messaging Describes use of predefined Performs predefined Develops ad hoc queries for Maps electronic data to form modules to deliver queries of analytical data electronic messaging messages consistent with predefined messages to for electronic messaging client message structure, partners format, and vocabulary for export
INF 8.03. Electronic messaging Describes predefined Sends automated electronic Determines secure Ensures the use of secure transport electronic messaging results to partners electronic messaging electronic messaging transport protocols§ according to established transport protocols transport protocols electronic messaging transport protocols
INF 8.04. Message vocabulary Describes vocabulary Verifies local codes are Evaluates processes that Automates the mapping of necessary for data pre-mapped to nationally automate the linking of test codes and results to all exchange accepted standard codes local and national codes standardized notifiable for test requests and test diseases and conditions results
INF 8.05. Test order creation Describes standard test Communicates test orders Manages the automation of Develops protocols for order vocabulary with partners using test orders in collaboration automated electronic test predefined modules with partners order creation
INF 8.06. Test order receipt and Describes standard test Processes test orders Manages the automation of Develops protocols for notification order receipt and received from partners test order receipts and electronic test order notification vocabulary using predefined modules notification in collaboration receipts and notification with partners
INF 8.07. Test results reporting Describes standard test Communicates test results Manages the automation of Develops protocols for results vocabulary with partners using test results reporting in electronic test order results predefined modules collaboration with partners reporting
INF 8.08. Test results Describes test results receipt Verifies test results receipt Manages the automation of Develops protocols for acknowledgment acknowledgment with partners using test results receipts in electronic test results predefined modules collaboration with receipts partners
INF 8.09. Exchange networks Describes exchange Performs routine data Troubleshoots exchange Manages the workflow and networks exchange using network interfacing operation of exchange predefined modules networks according to information exchange standards
See table footnotes on page 61.
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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 Enters meta data and Verifies the collection and Ensures the ability to capture, Develops modules and demographic data demographic data editing of meta data and retrieve, and link meta data workflows to electronically associated with laboratory demographic data using and demographic data capture, retrieve, and link testing predefined modules associated with laboratory meta data and demographic testing data associated with laboratory testing
INF 9.02. Statistical analysis Explains how automated Performs predefined Develops ad hoc queries to Writes code or procedure statistical evaluation tools queries on collected data collect extracts of data for code for third-party link meta data and for predefined statistical unique statistical analyses software to automate the demographic data within analyses to link meta data to link meta data and querying and reporting of reports and demographic data demographic data within statistical data to link meta within reports reports data and demographic data within reports
INF 9.03. Laboratory performance Describes the production of Provides reporting and Develops ad hoc statistical Develops workflows and analyses laboratory performance evaluation of laboratory analyses to evaluate key automation tools to ensure reports program performance data performance indicators the implementation of using predefined reports laboratory performance- based analyses
INF 9.04. Spatial data Describes modules for Uses predefined tools to Evaluates the availability of Develops modules for entering geographic integrate GIS data with validated tools to integrate LIMS-associated or information system (GIS) laboratory testing results GIS data with laboratory third-party software to data and with meta and testing results and with integrate GIS data with demographic data meta and demographic laboratory testing results data 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) Troubleshoots billing data Evaluates the automated Develops workflows and with associated laboratory associated with laboratory capability to link billing modules to manage the services at time of services data with laboratory collection of financial data accessioning services
INF 10.02. Accounts receivable* Enters billing data in an Performs advanced Manages accounts Develops workflows and accounts receivable functions of automated receivable systems modules to automate the program electronic billing and regarding billing of integration of billing linking of laboratory services rendered information with accounts services to accounts receivable software and receivable systems financial services
INF 10.03. Cost of testing and Identifies accounting codes Verifies that correct Manages accounts for cost Develops workflows and other laboratory services assigned for laboratory accounting codes are of laboratory services to modules to track the cost of services rendered consistent with the cost of individual customers laboratory services with services and are linked to customers and to manage laboratory services the accounts receivable rendered system
See table footnotes on page 61.
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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 Describes billing functions Verifies that accounting of Evaluates centralized Develops workflows and laboratory billing with for multiple systems that laboratory services is functionality regarding an systems to consolidate enterprisewide billing handle billing of laboratory being collected from enterprise-wide capability cross-enterprise billing and services disparate systems to account for costs accounting for laboratory services
INF 10.05. Budgeting* Describes billing modules Performs routine reporting Generates detailed Develops systems to link of billing and revenue data budgetary summaries of billing data for budgeting for fiscal analyses billing data and trend analysis
INF 11.00. Contract* and grant* management: manages grants and contractual instruments* Subcompetency Beginner Competent Proficient Expert INF 11.01. Document Describes centralized Verifies the entry and Evaluates document Develops enterprise-wide management systems electronic document timeliness of laboratory management systems to workflows and management systems that program deliverables into recommend communications to ensure track and store grants, document management improvements and an automated and secure contractual instruments, systems efficiency and to meet document management and project management* contractual and grant system for grants and materials obligations contractual instruments
INF 11.02. Contractual instruments Describes informatics Verifies the use of existing Manages contractual Creates contractual support available to contractual instruments instruments instruments with partners laboratory through to ensure informatics and contractual instruments information technology (IT) needs are captured
INF 11.03. Activity tracking Describes informatics Tracks activities and Evaluates the laboratory’s Develops systems to define, contractual and grant deliverables of grants and ability to track delivery of organize, monitor, and deliverables contractual instruments individual informatics track the activities of grants using predefined components related to and contractual electronic modules budgetary, personnel, instruments with outside legal, and laboratory parties using electronic procedures and processes processes
INF 11.04. Enterprise-wide systems Describes contractual Explains contractual Evaluates informatics Develops an enterprise-wide informatics instruments instruments developed for contractual instruments approach to information relevant to the enterprise individual laboratory with outside parties using systems implementation programs for enterprise electronic documentation management processes
INF 12.00. Training, education, and resource management: manages training, education, and information resources Subcompetency Beginner Competent Proficient Expert INF 12.01. Electronic master Accesses electronic Verifies that electronic Evaluates that electronic Develops modules to ensure record* information on staff documentation of training, documentation of training, electronic content, access, training, education, and education, and education, and related and security exist to meet capabilities management of information meets the educational needs of educational resources is operational requirements the laboratory up-to-date
INF 12.02. Resource summaries Lists available electronic Verifies that electronic Evaluates the need for Develops modules to ensure reports that summarize reports regarding additional and revised electronic summary reports laboratory resources, laboratory resources are reports on laboratory of laboratory resources are including staff accurate and complete resources available
See table footnotes on page 61.
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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 Verifies that informatics Evaluates laboratory Develops informatics systems for tracking processes remain informatics needs to programs to ensure that documented staff needs up-to-date and ensure the existence of staff education and training and knowledge gained demonstrate the acquired resources and avenues to is aligned with the business from training informatics capabilities of support staff education needs and directions for opportunities staff and training laboratory services and the professional growth of staff
INF 12.04. Training activities for Describes existing electronic Verifies electronic Evaluates electronic training Develops electronic training external partners documentation on documentation on training activities for external materials and associated trainings offered to activities for external partners to ensure they documentation for external external partners partners are accurate and meet current and future partners complete requirements
INF 12.05. Knowledge Describes own role(s) in Verifies the participation Evaluates the effectiveness Develops a strategy for the management (KM)* supporting the collective and integration of of electronic KM practices creation, collection, and knowledge within a program staff to ensure organizationally management of KM laboratory program electronic KM within the performance measures organization electronically
INF 12.06. Lifecycle management Describes laboratory IT Ensures the use of IT project Evaluates staff compliance Develops a comprehensive strategy* for IT investments project management management resources with a comprehensive laboratory IT lifecycle resources lifecycle management management strategy strategy for IT investments
INF 12.07. Informatics Describes the strategy for Ensures the implementation Evaluates staff compliance Develops a strategy for communication strategy communicating with of the communication with the communication communication of internal and external strategy strategy informatics capabilities and partners regarding resourcing priorities to informatics capabilities internal and external and resourcing priorities 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, Explains applicable CAL Verifies the implementation Evaluates electronic data Develops workflows and accreditation, and licensing (CAL) electronic data of predefined data processing standards in modules to automate compliance requirements related to processing standards and order to ensure laboratory laboratory adherence to work area form management adherence to current and data processing standards associated with CAL for a new CAL requirements associated with CAL laboratory program
INF 13.02. External certification Enters data into predefined Verifies performance of Evaluates current Develops electronic modules modules predefined electronic capabilities to manage to automate the systems regarding external external certifications and management of external certifications future needs certifications
INF 13.03. Privacy and security Describes electronic Ensures that individual Evaluates individual Develops workflows and standards for own job laboratory programs electronic security and modules to ensure classification related to the adhere to electronic privacy standards that the electronic systems meet privacy and security of security and privacy laboratory must meet security and privacy protected information* standards standards and adhere to regulatory requirements
See table footnotes on page 61.
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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 Describes predefined Verifies the implementation Evaluates current and future Develops workflow and feedback modules to record of predefined modules to needs to handle customer modules that automate the customer and staff record customer and staff relationships and perform collection of data to track feedback feedback ad hoc queries to improve and to perform ad hoc regulatory compliance and queries and reporting of business management customer and staff feedback
INF 14.02. Tracking laboratory Describes predefined Verifies the implementation Evaluates current and future Develops workflow and errors and information requests modules to record of predefined modules to needs to track and modules that automate the laboratory errors and record laboratory errors perform ad hoc queries on collection of data to track information requests and information requests laboratory errors and and to perform ad hoc information requests queries and reporting of laboratory errors and information requests
INF 14.03. Tracking corrective Describes predefined Verifies the implementation Evaluates current and future Develops workflow and actions and reports modules that summarize of predefined modules to needs to track, perform ad modules that automate the reporting and corrective summarize corrective hoc queries, and provide collection of data to track actions actions and generate reports regarding and to perform ad hoc reports corrective actions 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 Describes predefined Verifies the electronic Evaluates automated Develops automated sample results modules that collect QC set-up, extraction, and systems for QC data set up, processes for QC data set data associated with transmission of QC data extraction, and up, extraction, and sample results using predefined modules transmission transmission and data capture utilities for automated instruments
INF 15.02. Data review and Lists QC data that are Performs review and Validates final data prior to Develops workflows and validation collected electronically to validation of data release to customers using modules to assist in support validation of test configurable rules-based automating the validation results functionality of test results
INF 15.03. Data trending Enters QC data to support Verifies the use of Evaluates automated Develops the workflows and tracking, trending, and automated software to tracking, trending, and automation processes to analysis of method support analysis of QC analysis of method support automated accuracy and precision data related to tracking, accuracy and precision tracking, trending, and trending, and analysis of analysis of method method accuracy and accuracy and precision precision
INF 15.04. QC reporting Uses predefined modules to Verifies the reporting and Evaluates automated Develops reports that meet produce electronic and evaluation of QC data reporting of QC data method requirements and paper results that include associated with analytical associated with analytical customer needs to capture QC data associated with testing using predefined batches and deliver QC data in test runs modules multiple formats and messages
See table footnotes on page 61.
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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 Describes organizational Performs day-to-day Evaluates organizational Develops informatics management systems (QMS)* structure, policies, oversight of organizational structure, policies, workflows and the processes, procedures, and structure, policies, processes, procedures, and organizational structure, resources that address QA processes, procedures, and resources that address policies, processes, related to informatics resources that address QA- and QMS-related to procedures, and resources activities QA- and QMS-related to informatics activities to address QMS and QA informatics activities related to informatics activities
INF 15.06. Responses to QC data Describes data elements Verifies that data to support Validates data elements Develops automated needed to support auto-alerts, qualifiers, or using configurable workflows to provide automated auto-alerts, triggering of responses to rules-based functionality auto-alerts, qualifiers, and qualifiers, or triggering of QC data are associated to provide auto- alerts, triggering of responses to responses to QC data with test results qualifiers, or triggering of QC data 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* Describes electronic data Verifies the central Evaluates the electronic, Develops an electronic, management entry and access to management of hazardous centralized management centralized system to hazardous material materials using predefined of hazardous materials manage hazardous locations, safety data electronic modules for materials sheets (SDS),* procedures, reporting and tracking disposal records* current practice standards, and master records
INF 16.02. Incident* tracking Describes predefined Ensures staff compliance Manages laboratory Develops electronic modules to track incidents with electronic reporting electronic safety and workflows, processes, and of laboratory safety accident investigation procedures to track and activities and accident processes and procedures manage safety and investigations accident investigations
INF 16.03. Select agent* Describes predefined Ensures staff compliance Evaluates automated Develops electronic modules management modules related to the with regulations processes to adhere to the that adhere to the federal federal Select Agent associated with the federal federal Select Agent Select Agent Program and Program* and registry Select Agent Program and Program and registry registry registry
INF 16.04. Hazardous material Describes system alerts Verifies the generation of Evaluates current and future Develops electronic modules alerts* associated with hazardous package and sample labels electronic hazardous to manage and track materials once an alert is received material alert activities associated with electronically requirements hazardous material alerts
INF 16.05. Hazardous risk Lists electronic central Verifies that documentation Evaluates the Develops task workflow management documents that define systems track laboratory documentation systems analyses to ensure the laboratory processes processes related to for laboratory processes electronic management of related to hazardous risk hazardous risk related to hazardous risk hazardous risks management management management
See table footnotes on page 61.
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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 Outlines coverage of Verifies that laboratory Evaluates the informatics Develops informatics COOP Operations Plan (COOP)* informatics and IT services program responsibilities and IT aspects of the workflows and procedures within the laboratory’s are carried out during the laboratory COOP to ensure to restore informatics and COOP implementation of a COOP they are complete and IT support up-to-date
INF 17.02. COOP contractual Describes COOP formal Verifies the performance of Manages the Develops work plans and instruments contractual instruments laboratory program documentation project management involving informatics informatics responsibilities supporting existing processes to ensure that pertaining to COOP informatics contractual comprehensive informatics contractual instruments instruments pertaining to contractual instruments are disaster recovery and in place mutual assistance through drills
INF 17.03. Electronic catalogue of Explains the importance of a Verifies the accuracy and Evaluates electronic Develops workflows and capacities and services catalogue of electronic access to a catalogue of catalogue capabilities, project management capabilities and services, electronic capabilities, services, and schedules for processes to validate the and of schedules for services, and schedules for testing their effectiveness electronic catalogue of testing their effectiveness testing their effectiveness during disaster recovery capabilities, services, during disaster recovery during disaster recovery and emergency situations schedules, and testing of and emergency situations and emergency situations 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 Employs client-side Verifies the correct use of Evaluates modifications, Evaluates client-side options software computer systems LIMS and advanced use of upgrades, and new regarding LIMS installation, including LIMS access office software releases to laboratory management, and use protocols and routine instrument software and office software systems
INF 18.02. Electronic Describes communication Determines content for Evaluates the use and Develops the technology to communication tools for electronic electronic information requirements of electronic support electronic information communication tools information information communication tools communication tools
INF 18.03. Enterprise-wide LIMS Describes LIMS Verifies LIMS processes for Evaluates LIMS functionality Manages the continuous availability management processes data collection, data to meet laboratory and availability and processing and reporting customer needs development of an for laboratory business enterprise-wide LIMS to needs ensure a fully functional and mature system
INF 18.04. Networking Describes network access Verifies laboratory use of Evaluates the use of Manages the administration protocols and use of the predefined network networks to support of network servers laboratory network protocols laboratory activities
INF 18.05. IT help desk Describes access to available Documents the delivery of Evaluates IT support needed Develops formal contractual IT support support to laboratory for laboratory operations instruments, workflows, programs and project management processes for the delivery of IT support throughout the laboratory
See table footnotes on page 61.
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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 Describes the processes to Verifies needs for software Evaluates the resources that Manages the SDLC at the life cycle (SDLC)* use and improve electronic process improvements impact the SDLC enterprise-level, including laboratory workflows and change management* algorithms
INF 18.07. Enterprise integration Lists predefined functions Verifies the use of Evaluates integration Develops automated engine* that use an integration predefined integration functions with partners workflows and processes engine engine modules and customers 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 Evaluates the accessibility Develops workflows and of, legacy data systems and searchability of legacy processes to ensure that data legacy data are accessible and searchable
INF 18.09. LIMS communication Describes predefined Verifies the proper use of Evaluates the ability of the Develops workflows and with third-party data systems modules to support LIMS predefined modules to LIMS to communicate with processes to support LIMS communication with support LIMS third-party data systems communications with third-party data systems communication with third-party systems third-party data systems
INF 18.10. Access and audit trails Describes modules that Verifies staff access to Evaluates the ability of the Develops protocols to provide a view of audit electronic audit trails LIMS to manage access manage access and audit trails and audit trails trails
INF 18.11. Instrument analysis Describes instrument Uses instrument analysis Evaluates analytical Develops analytical software analysis software systems software instrument software instrument software systems
INF 18.12. Computer maintenance Identifies basic computer Performs routine computer Performs complex Manages the computer and troubleshooting problems maintenance and computer maintenance maintenance and troubleshooting and troubleshooting 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 Ensures laboratory program Evaluates informatics Develops processes for informatics policies adherence to existing policies informatics policy making informatics policies
INF 19.02. Change control¶ Describes change control Ensures laboratory program Evaluates the effectiveness Develops informatics processes related to adherence to the change of change control policies, processes, and informatics control processes related processes related to procedures to manage to informatics informatics change control and ensure staff compliance
INF 19.03. Documentation for Provides documentation for Verifies that paper and Evaluates completeness of Develops workflows and standardized laboratory IT standardized laboratory IT electronic documentation documentation for processes to ensure paper processes processes of laboratory IT processes standardized laboratory IT and electronic are centrally located and processes documentation is centrally accessible located and accessible
INF 19.04. Operational budgeting Describes the importance of Identifies informatics Evaluates the operational Develops a budgeting strategy electronic budgetary business needs of the budgeting strategy strategy for the laboratory’s processes laboratory program for informatics systems and operational budgeting services strategizing
See table footnotes on page 61.
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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 Provides the listing of Evaluates capital budgeting Develops capital budgets for budgeting processes for capital budget needs needs regarding electronic information informatics-related assets* regarding laboratory laboratory informatics systems and services informatics
INF 19.06. Partnership channels Lists established Presents short- and Ensures that laboratory Develops partnerships to stakeholders and long-term informatics informatics business needs facilitate funding for partnership channels business needs to are presented to informatics management staff stakeholders and partnership channels
* 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.
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Microbiology Competency The testing services address multiple modes of transmission and include molecular methods for epidemiology and disease Guidelines surveillance. In addition, public health laboratories provide Purpose statement: The competencies in Microbiology many specialized tests that are not commercially available. address the knowledge, skills, and abilities needed to safely Notes: Multiple sources were identified as support and securely detect, identify, and report infectious agents of documents for this domain (26,51,59,61,62,82). This domain concern to the public while following the laboratory path of is not expected to be all-inclusive of functions performed in workflow (Table 12). every microbiology subspecialty in the laboratory. The General Introduction: Microbiology is the scientific study of Laboratory Practice and Safety domains are companions to microorganisms and infectious agents as applied to the this domain; all are intended to be used together, though some diagnosis, treatment, and prevention of disease, disability, and overlap in content exists. The verb “oversees” is used extensively death. Microbiology includes the subspecialties of virology, in the Expert level. In this context, “oversees” is a broad term mycology, parasitology, mycobacteriology and bacteriology that comprises the many functions related to the management that are encompassed in the disciplines of clinical, food, and of policies, processes and procedures to include creation, environmental microbiology. design, development, directing, monitoring, evaluation, and Microbiology is critical to the public health role of detecting collaboration. There is an assumption for the Beginner level, and identifying outbreaks, emerging diseases, and biological especially with use of the verbs “performs” and “adheres to,” threats. Public health laboratories serve many public health that there is a degree of training and supervision still occurring programs and provide reference and specialized testing that that is providing needed guidance and information (e.g., on relate to disease control and prevention in the population. why it is critical to perform steps and processes as directed).
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 Describes basic Relates microbiological Ensures microbiological Evaluates laboratory concepts and theories* microbiological concepts concepts and theories to concepts and theories are practices for adherence and theories the specific tests that are applied in laboratory testing to accepted conducted microbiological concepts and theories
MCB 1.02. Basic microbiological Applies basic Integrates basic Trains staff on basic Ensures implementation of techniques microbiological microbiological techniques microbiological techniques basic microbiological techniques to laboratory into new laboratory techniques into testing practices and procedures* 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 Recognizes laboratory Instructs others on Ensures staff compliance with Develops policies, related to microbiological agents hazards and hazard laboratory hazards and policies, processes,* and processes, and communication* related hazard communication procedures addressing procedures regarding to microbiological agents related to microbiological laboratory hazards related hazards related to agents to microbiological agents microbial agents based on risk assessments†
MCB 2.02. Safe work practices* Adheres to policies, Instructs others in policies, Ensures staff compliance with Creates a culture of biosafety processes, and procedures processes, and procedures policies, processes, and by ensuring that policies, regarding safe work regarding safe work procedures regarding safe processes, and procedures practices related to practices related to work practices related to regarding safe work microbiological agents microbiological agents microbiological agents practices related to microbiological agents are aligned with current standards and regulatory requirements
See table footnotes on page 67.
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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 Adheres to policies, Instructs staff in policies, Ensures staff compliance with Establishes policies, equipment (PPE)* processes, and procedures processes, and procedures policies, processes, and processes, and regarding PPE use for regarding PPE use for work procedures regarding PPE procedures regarding work related to related to microbiological use for work related to PPE use for work related microbiological agents agents microbiological agents to microbiological agents
MCB 2.04. Biosafety cabinets and Adheres to policies, Instructs staff in use of Ensures laboratory adherence Establishes policies, other engineering controls* processes, and procedures biosafety cabinets and to biosafety cabinet processes, and regarding the use of other engineering controls certification* and staff procedures, including biosafety cabinets and compliance with policies, training, to ensure other engineering controls processes, and procedures implementation and use regarding the use of biosafety of biosafety cabinets and cabinets and other other engineering engineering controls controls
MCB 2.05. Waste management Adheres to policies, Instructs staff in waste Establishes waste Oversees the waste related to microbiological agents processes, and procedures management policies, management processes and management plan* regarding waste processes, and procedures procedures related to related to microbiological management related to related to microbiological microbiological agents agents microbiological agents agents
MCB 2.06. Decontamination* Adheres to policies, Instructs staff in the policies, Ensures staff compliance with Develops policies, processes, and procedures processes, and procedures policies, processes, and processes, and regarding regarding procedures regarding procedures related to decontamination decontamination for decontamination decontamination different microorganisms
MCB 2.07. Storage of Adheres to policies, Instructs staff in policies, Ensures staff compliance with Develops policies, microbiological materials processes, and procedures processes, and procedures policies, processes, and processes, and regarding storage of regarding the storage of procedures that address the procedures related to the microbiological materials microbiological materials storage of microbiological storage of for different microorganisms materials 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, Describes routine sample Consults on nonroutine Monitors staff compliance Oversees the policies, labeling, and handling collection, labeling, and sample collection, labeling, with established policies, processes, and handling policies, and handling procedures processes, and procedures procedures for sample processes, and procedures for microbiological regarding microbiological collection, labeling, and for microbiological examination sample collection, labeling, handling for examination and handling microbiological examination
MCB 3.02. Packaging and shipping Performs packing and Instructs others on packing Ensures staff compliance with Develops policies, shipping of Category A* and shipping of Category policies, processes, and processes, and and Category B* infectious A and Category B procedures regarding the procedures to ensure substances infectious substances packing and shipping of staff compliance with Category A and Category B packing and shipping infectious substances regulations concerning Category A and Category B infectious substances
MCB 3.03. Material transport Describes the importance Instructs others on Develops microbiological Oversees the policies, of adhering to established microbiological material material transport processes processes, and policies, processes, and transport policies, and procedures procedures regarding procedures regarding processes, and procedures microbiological material microbiological material transport transport
See table footnotes on page 67.
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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, Adheres to policies, Ensures staff compliance with Oversees the policies, processes, and procedures processes, and procedures policies, processes, and processes, and for the identification, regarding the procedures regarding the procedures regarding the handling, safety, identification, handling, identification, handling, identification, handling, appropriateness and safety, appropriateness safety, appropriateness and safety, appropriateness triage of samples and triage of samples triage of samples containing and triage of samples containing agents of containing agents of agents of concern containing agents of concern concern concern
MCB 3.05. Accessioning and Performs procedures for Instructs staff in policies, Develops processes and Oversees the policies, receipt accessioning and receipt processes, and procedures procedures for processes, and of microbiological samples regarding accessioning microbiological sample procedures regarding and receipt of accessioning and receipt microbiological sample microbiological samples accessioning and receipt
MCB 3.06. Sample tracking Performs systematic Instructs staff on policies, Develops processes and Oversees the policies, tracking of microbiological processes, and procedures procedures for the processes, and samples from receipt to for the systematic tracking systematic tracking of procedures for the final disposition of microbiological samples microbiological samples systematic tracking of from receipt to final from receipt to final microbiological samples disposition disposition from receipt to final disposition
MCB 3.07. Sample evaluation and Assesses sample Instructs others in the Develops processes and Oversees the policies, appropriateness* for testing appropriateness for a appropriateness of routine procedures for assessment processes, and particular microbiological and nonroutine samples of routine and nonroutine procedures regarding examination for microbiological sample appropriateness for assessment of routine examination microbiological examination and nonroutine sample appropriateness for microbiological examination
MCB 3.08. Testing workflow§ Adheres to policies, Instructs staff in policies, Ensures staff compliance with Establishes policies, processes, and procedures processes, and procedures policies, processes, and processes, and regarding testing regarding testing workflow procedures related to procedures related to workflow testing workflow testing workflow
MCB 3.09. Nucleic Acid Adheres to policies, Instructs staff in policies, Ensures staff compliance with Establishes policies, Amplification Tests (NAAT) processes, and procedures processes, and procedures policies, processes, and processes, and workflow (facility specific) regarding NAAT workflow regarding NAAT workflow, procedures regarding NAAT procedures for NAAT including pre- and workflow workflow postamplification areas
MCB 3.10. Sample set-up Performs sample set-up Instructs staff in sample Develops processes and Oversees the policies, procedures for set-up for microbiological procedures regarding processes, and microbiological examinations sample set-up for procedures regarding examinations microbiological sample set-up for examinations microbiological examinations
MCB 3.11. Sample storage and Performs procedures for Instructs staff in procedures Develops processes and Oversees the policies, handling microbiological sample for microbiological sample procedures for processes, and storage and handling prior storage and handling prior microbiological sample procedures regarding to examination to examination storage and handling prior microbiological sample to examination storage and handling prior to examination
MCB 3.12. Epidemiologic Describes which Reports to epidemiologists Ensures staff compliance with Oversees the policies, collaboration microbiological when microbiological policies, processes, and processes, and examination requests examination requests procedures for notification procedures for require epidemiologic warrant notification and consultation with notification and notification and epidemiologists regarding consultation with consultation microbiological examination epidemiologists requests regarding microbiological examination requests
See table footnotes on page 67.
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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 Prepares culture media Instructs staff on the Ensures staff compliance Oversees the policies, media according to policies, preparation of culture with policies, processes, processes, and procedures processes, and procedures media and procedures regarding for media preparation quality practices for media preparation
MCB 4.02. Selection of media Selects media according to Instructs staff in the media Ensures staff compliance Oversees the policies, procedures selection process with policies, processes processes, and procedures and procedures regarding regarding media selection quality practices for media selection
MCB 4.03. Culture inoculation Performs culture Instructs staff in how to Ensures staff compliance Oversees the policies, inoculation using aseptic inoculate cultures using with policies, processes processes, and procedures techniques aseptic technique and procedures regarding regarding culture quality practices for culture inoculation inoculation
MCB 4.04. Microscopic Recognizes the Instructs staff in Ensures staff compliance Oversees the policies, examination with morphological morphological morphological with policies, processes processes, and procedures characteristics characteristics of different identification and and procedures regarding regarding morphological organisms differentiating organisms quality practices for identification from artifacts morphological identification
MCB 4.05. Culture growth Recognizes growth Instructs staff in identifying Ensures staff compliance Oversees the policies, characteristics characteristics of growth characteristics of with policies, processes processes, and procedures microorganisms microorganisms and procedures regarding for interpretation of quality practices for microorganism growth identifying microorganism characteristics growth characteristics
MCB 4.06. Manual identification* Performs identification and Instructs staff in the Ensures staff compliance Oversees the policies, and susceptibility testing* susceptibility testing using performance of with policies, processes, processes, and procedures methods manual methods identification and and procedures regarding regarding the susceptibility testing using quality practices for performance of manual methods performing identification identification and and susceptibility testing susceptibility testing using using manual methods manual methods
MCB 4.07. Automated Performs identification and Instructs staff in the Ensures staff compliance Oversees the policies, identification* and susceptibility susceptibility testing using performance of with policies, processes, processes, and procedures testing* systems automated systems identification and and procedures regarding regarding the susceptibility testing using quality practices for performance of automated systems, performing identification identification and including how to utilize and susceptibility testing susceptibility testing using algorithms to determine using automated systems automated systems additional testing
MCB 4.08. Agent-specific antigen Performs antigen detection Instructs staff in how to Ensures staff compliance Oversees the policies, detection* methods perform antigen detection with policies, processes, processes, and procedures methods and procedures regarding for antigen detection quality practices for antigen detection methods
MCB 4.09. Nucleic acid (NA) Performs NA sequencing of Instructs staff in the Ensures staff compliance Oversees the policies, sequencing of infectious agents infectious agents performance of NA with policies, processes, processes, and procedures sequencing for the and procedures regarding regarding NA sequencing identification of infectious quality practices for NA and sequence-based agents sequencing of infectious identification agents, including the selection and utilization of databases
See table footnotes on page 67.
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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 Ensures staff compliance Oversees the policies, perform strain typing with policies, processes, processes, and procedures and procedures regarding regarding strain typing quality practices for strain typing
MCB 4.11. Rule-out testing for Explains the policies, Performs rule-out testing Ensures the laboratory Oversees the policies, agents of concern processes, and procedures and referral for responds quickly to needs processes, and procedures regarding rule-out testing identification, for rapid testing with regarding rule-out testing and referral confirmation, and timely notification and and referral characterization of agents secure messaging of results of concern
MCB 4.12. Quality control (QC)* Performs QC activities Interprets QC data prior to Examines QC data over time Ensures the QC program analysis reporting results to establish QC ranges and adheres to regulatory limits 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 Evaluates QC data for a Ensures staff compliance with Oversees the policies, evaluation given data reporting established policies, processes, and period processes, and procedures procedures related to QC for QC evaluation activities evaluation activities
MCB 5.02. Test analysis and results Assembles test data for Analyzes test data Interprets complex or Oversees the policies, interpretation review and action ambiguous results processes, procedures, and algorithms related to data analysis and results interpretation
MCB 5.03. Results reporting and Adheres to policies, Instruct staff in the policies, Ensures staff compliance with Oversees the policies, data release processes and procedures processes, and procedures policies, processes and processes, and related to reporting and related to reporting and procedures related to procedures, related to release of examination release of examination reporting and release of reporting and release of results and notifiable results and notifiable examination results and examination results and results* results notifiable results notifiable results to partners
MCB 5.04. Quality assurance (QA)* Explains the differences Collects data for reporting Evaluates QA indicator data Oversees the policies, between QA and QC on QA indicators processes, and procedures related to QA
See table footnotes on page 67.
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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 Recognizes NCEs in Documents NCEs on Analyzes NCEs for corrective Designs a management (NCE)* tracking laboratory processes discovery for actions and documentation system for NCEs implementation of corrective actions
MCB 6.02. Proficiency testing (PT)* Performs PT and alternative Reviews PT and alternative Monitors to ensure the PT Oversees the policies, and alternative assessment* assessment assessment results and alternative assessment processes, and program meets regulatory procedures related to PT requirements and alternative assessments
MCB 6.03. Method validation* and Participates in performance Compiles results of method Evaluates method validation Oversees the policies, performance verification* of method validation and validation and and performance processes, and performance verification performance verification verification results procedures related to method validation and performance verification
MCB 6.04. Development and Participates in the Evaluates LDT validation Creates processes and Oversees the policies, validation of laboratory- development of LDTs data procedures for the processes, and developed tests (LDTs)* development and validation procedures regarding the of LDTs development and validation of LDTs
MCB 6.05. Select agents* Describes the policies, Complies with policies, Implements policies, Oversees select agent processes, and procedures processes, and procedures processes, and procedures security, biosafety, related to the federal related to the federal regarding select agent testing, and incident Select Agent Program,* Select Agent Program, security, biosafety, testing, response plans to ensure including the securing, including the securing, and incident response alignment with select safe handling, and testing safe handling, and testing plans* agent regulations of select agents and the of select agents and the documentation of documentation of activities activities
* 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.
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Chemistry Competency Guidelines exposures through epidemiological programs’ studies. They also aid in the response to chemical emergencies or chemical Purpose statement: The competencies in Chemistry address terrorism events by providing rapid and definitive testing to the knowledge, skills, and abilities needed for the qualitative identify and quantify chemical agents. and quantitative analysis of chemicals of concern to the public Notes: Sources were identified as support documents for this in biological and environmental matrices (Table 13). domain (60,83). This domain is not expected to be all-inclusive Introduction: Chemistry is the science of detection, of all chemistry-related laboratory activities. The General measurement, and characterization of chemicals of public Laboratory Practice and Safety domains are companions to health importance in samples (e.g., human and animal, food this domain; all are intended to be used together, though some and feed, water and soil). Chemistry encompasses numerous overlap in content exists. The verb “oversees” is used often in subdisciplines in areas of both organic and inorganic testing. the Expert level. In this context, “oversees” is a broad term Chemistry programs within public health laboratories that comprises the many functions related to the management provide a first line of defense in the rapid recognition of toxic of policies, processes and procedures to include creation, chemical exposures and also support environmental health and design, development, directing, monitoring, evaluation, and epidemiological programs that investigate human exposures collaboration. There is an assumption for the Beginner level, to chemicals in the environment. Chemistry programs also especially with use of the verbs “performs” and “adheres to,” provide a wide array of specialized services related to clinical that there is a degree of training and supervision still occurring diagnostics for evaluating individual health, identification of that is providing needed guidance and information (e.g., on environmental health issues, and investigation of population why it is critical to perform steps and processes as directed).
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 Applies knowledge of the Integrates knowledge of the Differentiates chemical Integrates new properties properties of matter to properties of matter into properties to improve understandings of chemical assist in chemical analyses new chemical analyses chemical analyses properties to address occupational exposures or environmental or other public health issues
CHM 1.02. Chemical concepts Describes chemical concepts Applies chemical concepts to Differentiates chemical Formulates new chemical analyses concepts in analyses concepts to improve determinations
CHM 1.03. Laboratory Explains statistical concepts Collects data for statistical Evaluates summarized data Oversees the development statistics and practices analyses for statistical analyses and use of statistical programs
CHM 1.04. Equations and Performs chemical Instructs staff in the Determines when and which Oversees the use and calculations calculations performance of chemical chemical equations and interpretation of chemical calculations calculations are needed equations and calculations
CHM 1.05. Measurements Performs measurements and Instructs staff in Determines the needed Develops processes* and unit conversion calculations measurements and unit accuracy and precision of procedures* to maximize conversion calculations measurements the accuracy and precision of measurements and techniques
See table footnotes on page 71.
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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 Instructs others on chemical Implements hazard Develops strategies to reduce and chemical hazard hazards and hazard communication procedures chemical hazards based on communication* communication and training risk assessments†
CHM 2.02. Safe work Adheres to safe work Instructs others in safe work Ensures staff compliance with Creates a culture of safety by practices* practices related to practices, policies, and policies,* processes, and ensuring that policies, chemical hazards procedures related to procedures related to safe processes, and procedures chemical hazards work practices related to regarding safe work chemical hazards practices related to chemical hazards are aligned with current standards and regulatory requirements
CHM 2.03. Personal protective Adheres to policies, Instructs staff in the use of Ensures that staff are trained Establishes policies, equipment (PPE)* processes, and procedures PPE and comply with policies, processes, and procedures regarding PPE use processes, and procedures regarding the use of PPE regarding the use of PPE
CHM 2.04. Engineering Adheres to policies, Instructs staff in the use of Ensures that staff are trained Establishes policies, controls* processes, and procedures engineering controls and comply with policies, processes, and procedures regarding the use of processes, and procedures regarding the use of engineering controls regarding the use of engineering controls engineering controls
CHM 2.05. Waste Adheres to policies, Instructs staff in sample Establishes sample waste Oversees the sample waste management related to processes, and procedures waste management policies, management policies, management plan* samples* related to sample waste processes, and procedures processes, and procedures management
CHM 3.00. Pre-examination:* performs chemistry pre-examination procedures Subcompetency Beginner Competent Proficient Expert CHM 3.01. Sample collection, Describes routine sample Consults on nonroutine Monitors staff compliance Oversees the policies, labeling, and handling collection, labeling, and sample collection, labeling, with established policies, processes, and procedures handling policies, processes, and handling procedures for processes, and procedures for the collection and and procedures for chemical chemical examination regarding chemical sample handling of samples for examination collection, labeling, and chemical examination handling
CHM 3.02. Packaging and Performs the packing and Instructs others on packing Ensures staff compliance with Develops policies, processes, shipping shipping of hazardous and shipping of hazardous policies, processes, and and procedures to ensure samples samples procedures regarding the staff compliance with packing and shipping of packing and shipping hazardous samples regulations concerning hazardous samples
CHM 3.03. Material transport Describes the importance of Instructs others on material Develops material transport Oversees the policies, adhering to established transport policies, processes and procedures processes, and procedures policies, processes, and processes, and procedures for the transport of procedures regarding materials for chemical transport of materials for examination chemical examination
CHM 3.04. Chemical threats Describes the policies, Adheres to policies, Ensures staff compliance with Oversees the policies, processes, and procedures processes, and procedures policies, processes, and processes, and procedures for the identification, regarding the identification, procedures regarding the regarding the identification, handling, safety, handling, safety, identification, handling, handling, safety, appropriateness and triage appropriateness and triage safety, appropriateness and appropriateness and triage of samples containing of samples containing triage of samples containing of samples containing chemical agents of concern chemical agents of concern chemical agents of concern chemical agents of concern
See table footnotes on page 71.
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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 Performs procedures for Instructs staff on policies, Manages the policies, Designs policies, processes, receipt sample accessioning and processes, and procedures processes, and procedures and procedures regarding receipt regarding sample for sample accessioning and sample accessioning and accessioning and receipt receipt receipt
CHM 3.06. Sample tracking Performs systematic tracking Instructs staff on policies, Manages the policies, Designs polices, processes, of samples from receipt to processes, and procedures processes, and procedures and procedures for the final disposition for the systematic tracking for the systematic tracking systematic tracking of of samples from receipt to of samples from receipt to samples from receipt to final final disposition final disposition disposition
CHM 3.07. Sample evaluation Assesses appropriateness of Instructs others in Manages the policies, Establishes policies, and appropriateness* for routine samples for appropriateness of routine processes, and procedures processes, and procedures testing chemical examination and nonroutine samples for for assessment of routine regarding the assessment of chemical examination and nonroutine sample routine and nonroutine appropriateness for sample appropriateness for chemical examination chemical examination
CHM 3.08. Testing workflow§ Adheres to policies, Instructs staff in policies, Ensures laboratory processes Develops policies, processes, processes, and procedures processes, and procedures and procedures include use and procedures related to regarding testing workflow regarding testing workflow of testing workflow testing workflow
CHM 3.09. Sample processing Performs sample processing Performs sample processing Instructs staff on sample Develops policies, processes, procedures for routine for complex chemical processing for routine and and procedures regarding chemical examinations examinations complex chemical sample processing for examinations routine and complex chemical examinations
CHM 3.10. Pre-examination Performs procedures for Instructs staff in procedures Manages processes and Designs policies, processes, sample storage and sample storage and for sample storage and procedures for sample and procedures regarding handling handling prior to handling prior to storage and handling prior sample storage and examination examination to examination handling prior to examination
CHM 3.11. Epidemiologic Describes which chemical Reports to epidemiologists Manages the policies, Designs policies, processes, collaboration examination requests when chemical examination processes, and procedures and procedures regarding require epidemiologic requests warrant for notification and notification and notification and notification consultation with consultation with consultation epidemiologists regarding epidemiologists regarding chemical examination chemical examination requests requests
CHM 4.00. Examination:* performs chemistry examination procedures Subcompetency Beginner Competent Proficient Expert CHM 4.01. Examination Performs chemistry Instructs staff in chemistry Monitors staff compliance Oversees chemistry examination procedures examination procedures with chemistry examination examination policies, policies, processes, and processes, and procedures procedures
CHM 4.02. Chemical Performs routine chemical Performs nonroutine Selects chemical extractions Develops new and improved extractions extraction methods chemical extractions for an identified purpose types of chemical extractions
CHM 4.03. Quality control Performs QC activities Interprets QC data prior to Examines QC data over time Ensures the QC program (QC)* analysis reporting results to establish QC ranges and adheres to regulatory limits requirements*
CHM 4.04. Equipment Identifies basic laboratory Corrects equipment Monitors equipment Develops equipment troubleshooting equipment* problems problems or failures functioning during its troubleshooting processes lifecycle and procedures
See table footnotes on page 71.
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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 Performs procedures for Instructs staff in procedures Manages processes and Designs policies, processes, and handling after sample storage and for sample storage and procedures for sample and procedures for sample examination handling after examination handling after examination storage and handling after storage and handling after examination examination
CHM 5.00. Postexamination:* performs chemistry postexamination procedures Subcompetency Beginner Competent Proficient Expert CHM 5.01.QC evaluation Assembles QC data for Evaluates QC data for a given Ensures staff compliance with Oversees the policies, evaluation data reporting period established policies, processes, and procedures processes, and procedures related to QC evaluation for QC evaluation activities activities
CHM 5.02. Test analysis and Assembles test data for Analyzes test data Interprets complex or Oversees the policies, results interpretation review and action ambiguous results processes, procedures, and algorithms related to data analysis and results interpretation
CHM 5.03. Results reporting Adheres to policies, processes Instruct staff in the policies, Ensures staff compliance with Oversees the policies, and data release and procedures related to processes, and procedures policies, processes and processes, and procedures, reporting and release of related to reporting and procedures related to related to reporting and examination results and release of examination reporting and release of release of examination notifiable results* results and notifiable results examination results and results and notifiable results notifiable results to partners
CHM 5.04. Quality assurance Explains the differences Collects data for reporting on Evaluates QA indicator data Oversees the policies, (QA)* between QA and QC QA indicators processes, and procedures related to QA
CHM 6.00. Regulatory compliance: ensures regulatory compliance Subcompetency Beginner Competent Proficient Expert CHM 6.01. Nonconforming Recognizes NCEs in Documents NCEs on Analyzes NCEs for corrective Designs a management event (NCE)* tracking laboratory processes discovery for actions and documentation system for NCEs implementation of corrective actions
CHM 6.02. Proficiency testing Performs PT and alternative Reviews PT and alternative Monitors to ensure the PT Oversees the policies, (PT)* and alternative assessment assessment results and alternative assessment processes, and procedures assessment* program meets regulatory related to PT and alternative requirements assessments
CHM 6.03. Method Participates in performance Compiles results of method Evaluates method validation Oversees the policies, validation* and of method validation and validation and performance and performance processes, and procedures performance verification* performance verification verification verification results related to method validation and performance verification
CHM 6.04. Development and Participates in the Evaluates LDT validation data Creates processes and Oversees the policies, validation of laboratory- development of LDTs procedures for the processes, and procedures developed tests (LDTs)* development and validation regarding the development of LDTs 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.
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Bioinformatics Competency protein domains, and protein structures; and the development and implementation of tools that enable efficient access and Guidelines management of different types of information. Purpose statement: The competencies in Bioinformatics Bioinformatics capability and capacity have become address the knowledge, skills, and abilities needed to collect, progressively more important within public health laboratories classify, and analyze biological and biochemical information because of rapid advances in molecular technologies and through the development and use of computer databases, laboratory techniques. As a result, the amount of data that algorithms, and statistical techniques (Table 14). a typical laboratory can generate has increased dramatically Introduction: Bioinformatics is the field of science that over the past decade. This increase in data requires new bridges the gap between biology, computer science, and competencies for laboratory scientists to analyze and interpret information technology by merging them into a single large datasets, and communicate complex and complete results discipline. There are three important subdisciplines within to audiences of varied backgrounds. bioinformatics: the development of new algorithms and Notes: Sources were identified as support documents for this statistics with which to assess relationships among members domain (84,85). This domain is intended for all laboratory of large data sets; the analysis and interpretation of various scientists in addition to bioinformatics specialists. types of data including nucleotide and amino acid sequences,
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 Identifies potential biological Determines biological Evaluates the effectiveness of Selects biological problems biology principles problems to be addressed problems to be addressed the selected computer to be addressed by by computer science by computer science science technique(s) in computer science techniques techniques addressing biological techniques problems
BIO 1.02. Domain-specific Identifies computer science Applies computer science Evaluates computer science Develops new computer science principles domains* to apply to domains to biological domains to apply to understandings of biological problems problems biological problems 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 Compares findings to any Oversees selection of analysis to analyze trends related data sets advanced statistical and patterns and to draw methods applicable to conclusions related to the specific bioinformatics biological data analyses
See table footnotes on page 73.
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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 Determines options and Implements new software Creates stand-alone analysis and algorithms to use for parameters of tools to meet tools to address unmet tools any given analysis specified needs of a given needs or improve current data analysis processes*
BIO 3.02. Data interpretation Identifies data pertinent to Formulates results of Interprets results within the Generates hypotheses to the analysis problem analyses, including context of the analysis predict future implications information in the form of problem based on the evaluation of graphs, charts, and tables data analyses
BIO 3.03. Data visualization Uses data visualization and Selects visualization and Evaluates representation and Modifies existing visualization and representation representation tools to representation tools for visualization tools for and representation tools to present results of data specified bioinformatics summarizing data analyses provide insight into analyses problems bioinformatics analyses
BIO 3.04. Communication Discusses bioinformatics with Initiates bioinformatics Facilitates knowledge- Contributes to new findings other scientists within their collaborations with sharing with stakeholders and meaningful institution colleagues 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 Applies knowledge of data Manipulates data structures Develops new data structures knowledge of data structures to relevant to address biological structures problems problems
BIO 4.02. Data management Describes data management Applies knowledge of data Evaluates data management Develops new data techniques management techniques to techniques management techniques relevant problems
BIO 4.03. Data storage and Describes data storage and Applies knowledge of data Evaluates data storage and Develops new data storage retrieval retrieval techniques storage and retrieval retrieval techniques and retrieval techniques techniques
BIO 4.04. Allocation of Describe available computing Allocates computing Manages allocation of Develops new methods for computing resources resources and capacity resources multiple computing allocation of computing resources resources
* This term is defined in Appendix B.
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Research Competency Guidelines health laboratory community is also challenged by changes in virulence or drug susceptibility of pathogens, which impact Purpose statement: The competencies in Research address exposure investigation and response, and the need for advanced the knowledge, skills, and abilities needed to conduct a diagnostics and analyses to support surveillance. systematic, hypothesis-driven investigation that includes Notes: Multiple sources were identified as support research development, testing, and evaluation designed to documents for this domain (41,44,86,87). This domain is advance public health knowledge, methods, and/or practice intended for use in conjunction with the General Laboratory (Table 15). Practice and Safety domains. The verb “oversees” is used Introduction: Research is a systematic investigation designed extensively in the Expert level. In this context, “oversees” is to develop or contribute to generalizable knowledge. It also a broad term that comprises the many functions related to includes product or method development, assessment, and the management of policies, processes and procedures to evaluation. Scientific research provides information to solve include creation, design, development, directing, monitoring, new or existing problems, to reaffirm results of previous work, evaluation, and collaboration. This domain does not address and to support or develop new hypotheses. areas of assessment and evaluation of laboratory practices, Research is critical to the public health enterprise, as which is included in the Quality Management System and communities are continually challenged with new diseases Management and Leadership domains. and unknown environmental public health threats. The public
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 Describes the laboratory’s Illustrates how research Formulates research projects Develops hypothesis-driven and agenda research objectives projects fit within the that align with the research objectives and a laboratory’s research laboratory’s research research agenda for the objectives and agenda objectives and agenda laboratory
RES 1.02. Research funding Describes general funding Participates in writing Leads drafting of research Manages the overall mechanisms that support funding proposals for funding proposals processes* for obtaining public health research research projects and sustaining research funds
RES 1.03. Funding proposal Describes basics of the Reviews internal proposals to Serves as an ad hoc reviewer Serves on research proposal reviews proposal review process verify adherence to for research proposal review committees guidelines and reviews recommended principles
RES 1.04. Research staffing Describes own role as part of Recognizes research staffing Participates in hiring research Develops the strategic plan needs the research staff needs staff to recruit and retain researchers
RES 1.05. Research resource Uses financial and material Considers available financial, Assesses financial, human, Aligns financial, human, and management resources judiciously human, and material and material resources material resources to resources when planning when planning research support the research experiments projects program
RES 1.06. Regulatory Complies with regulatory Identifies noncompliance Manages processes regarding Ensures that laboratory requirements* requirements in the with regulatory staff compliance with programs operate performance of research requirements pertaining to regulatory requirements consistent with regulatory the performance of research concerning the requirements concerning performance of research the performance of research
See table footnotes on page 77.
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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 Complies with policies,* Instructs others in policies, Ensures staff compliance to Oversees the policies, research* processes, and procedures* processes, and procedures policies and procedures processes, and procedures related to ethical conduct in regarding ethical conduct in related to ethical research for implementing and research research practices maintaining ethical research practices
RES 2.02. Human and Complies with policies, Instructs others in policies, Ensures staff compliance to Oversees the policies, nonhuman subjects processes, and procedures processes, and procedures policies and procedures processes, and procedures related to doing research in related to doing research in related to doing research in for implementing and human and nonhuman human and nonhuman human and nonhuman maintaining ethical subjects subjects subjects practices* related to doing research in human and nonhuman subjects
RES 2.03. Collaboration Complies with established Describes complexities Ensures staff compliance with Builds research collaborations agreements with regarding issues of established agreements for collaborators collaboration, including research collaboration authorship
RES 2.04. Sharing research Complies with established Describes issues that might Ensures staff compliance with Establishes guidelines for data agreements pertaining to arise pertaining to data established agreements sharing research data research data sharing and ownership and the sharing regarding data sharing the use of intellectual of data property
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 Performs complex searches, Validates appropriateness of Rectifies gaps in data searches using a limited aggregating results from how searches are performed generated from searches number of sources multiple sources
RES 3.02. Critique of scientific Reads scientific and technical Assesses quality of literature Synthesizes scientific Evaluates scientific literature literature literature relevant to own and pertinence to own work evidence derived from and data to determine work literature impact on laboratory research programs
RES 3.03. Statistical concepts Recognizes meaning of Applies appropriate statistical Interprets statistical tests and Critiques statistical tests and and tests common statistical concepts concepts and tests in concepts used in literature concepts used in literature and tests performance of research
RES 3.04. Study designs Explains characteristics of Recognizes strengths and Considers study design Evaluates evidence-based common study designs limitations of study designs characteristics when research guidelines to select planning research activities or develop study designs
RES 3.05. Scientific and States scientific and technical Discusses scientific and Critiques scientific and Generates novel scientific technical concepts and concepts and procedures technical concepts and technical concepts and and technical concepts and procedures procedures procedures procedures
RES 3.06. Emerging trends States latest scientific and Discusses latest scientific and Identifies emerging trends in Analyzes emerging trends in technical advances relevant technical advances relevant scientific and technical scientific and technical to current research to current research advances and possible advances to make decisions impact to laboratory regarding impact on laboratory
See table footnotes on page 77.
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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 States the purpose of each Describes limitations of Proposes concepts for Oversees plans for the methodologies step in existing testing existing methodologies improved methodologies development of new methodologies employed methodologies
RES 4.02. Pilot testing, Contributes to pilot testing, Performs pilot testing, Designs strategies for pilot Oversees pilot testing, method validation,* and method validation, or method validation, or testing, method validation, method validation, and performance verification* performance verification performance verification or performance verification performance verification studies
RES 4.03. New methodology Participates in Implements new Manages implementation of Oversees the implementation application implementation of new methodologies into new methodologies of new methodologies methodologies laboratory practice 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 Explains how own tasks and Summarizes the public health Designs research projects Oversees research projects to design activities support specific issues and research address the identified public research projects questions addressed by health issues or questions specific research projects
RES 5.02. Experimental States the purpose of each Explains the overall Designs individual Generates the overall strategy and design step performed in individual experimental strategy experiments experimental strategy and experiments hypotheses for specific research projects
RES 5.03. Conduct of Uses established research Provides input regarding Develops research protocols Oversees the conduct of experiments protocols† research protocols and the to guide the conduct of experiments conduct of experiments 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 Records experimental Monitors quality and integrity Designs data collection and Develops policies, processes, quality* procedures and data of recorded information and entry methods that meet and procedures to ensure data data quality standards data quality and integrity
RES 6.02. Data management Complies with policies and Assists with the management Manages project data Oversees the management of procedures for data of data for individual research data for the management experiments laboratory
RES 6.03. Data analysis and Assists with data analysis of Analyzes project data Interprets data for individual Oversees data analysis plans results interpretation individual experiments research projects and results interpretation for the laboratory’s research projects
RES 6.04. Data summaries Describes data tables and Summarizes experimental Develops outlines and Critiques data summaries graphs data using multiple formats formats for data summaries
RES 6.05. Application of States laboratory’s research Examines the laboratory’s Implements integration of Oversees integration of research findings to current findings research data to determine internal and external internal and external research its significance in the research findings into research findings into context of the scientific laboratory’s research revised research agenda, literature practices objectives, and/or experimental strategies
See table footnotes on page 77.
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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 Attends institutional scientific Presents research to Presents research via oral Serves as an invited speaker conference presentations presentations colleagues within the presentation for discipline- at external meetings and organization or via poster at wide audiences conferences external events
RES 7.02. Manuscript Assists in manuscript drafting Drafts sections of research Publishes as first author or Publishes as senior author for preparation and editing manuscripts senior author in journals of multi-laboratory or the discipline multi-institutional research projects or in high-impact interdisciplinary journals
RES 7.03. Manuscript peer Reads drafts of manuscripts Informally critiques Participates in the peer Participates in the manuscript review process submitted for peer review manuscripts submitted for review process as a formal peer review process as peer review reviewer 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 States research findings as Describes implications of Directs translation of research Oversees translation of research findings into public they relate to current public research findings on public findings to public health research discoveries into health practice health practices health practices practices 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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Conclusion Acknowledgments The following persons contributed to this report: Joan Cioffi, PhD, These competency guidelines outline the knowledge, Office of Public Health Preparedness and Response, CDC; subject skills, and abilities needed by the PHL workforce to fulfill matter experts from the APHL Workforce Development Committee, the responsibilities of, and demands on, the PHL system. other PHL leadership and staff members, CDC, and practitioners They were developed with consideration of the diversity and from the American Society for Clinical Pathology, the American complexity of PHLs. The competencies should serve as a Society for Clinical Laboratory Science, the Association of Food and foundation for workforce development efforts to identify and Drug Officials, the Association of American Feed Control Officials, support training standards and performance expectations; the Coordinating Council on the Clinical Laboratory Workforce, the develop standardized job descriptions; periodically assess Clinical Laboratory Management Association, and the Clinical and individual staff and organizational capacity; and develop and Laboratory Standards Institute; Angela J. Beck, PhD, Matthew L. implement training plans with the competencies as a guide. Boulton, MD, University of Michigan Center of Excellence in Public The competency guidelines might also be used as a framework Health Workforce Studies. for developing progressive job series (career ladders) for PHL References workers, which has been identified as a significant barrier to 1. 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Wheat Ridge, Available at http://whqlibdoc.who.int/publications/2011/9789241548274_ CO: Association of Community Health Nursing Educators; eng.pdf?ua=1. 2011. Available at http://www.achne.org/files/Quad%20Council/ 41. Institute of Medicine. Integrity in scientific research: creating an QuadCouncilCompetenciesforPublicHealthNurses.pdf. environment that promotes responsible conduct. Washington, DC: The 23. National Commission for Health Education Credentialing. Areas of National Academies Press; 2002. Available at http://www.nap.edu/ responsibility, competencies, and sub-competencies for the health openbook.php?record_id=10430&page=R1. education specialists. Whitehall, PA: National Commission for Health 42. Jones NL. A code of ethics for the life sciences. Sci Eng Ethics 2007;13:25–43. Education Credentialing, Inc.; 2010. Available at http://www.nchec. 43. Public Health Leadership Society. Principles of the ethical practice of org/credentialing/responsibilities. public health. 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48. CDC. Public health preparedness capabilities: national standards for 68. National Research Council of the National Academies. Guide for the care state and local planning, capability 6: information sharing. Atlanta, GA: and use of laboratory animals. 8th ed. Washington, DC: National Academies US Department of Health and Human Services, CDC; 2011. Available Press; 2011. Available at http://oacu.od.nih.gov/regs/guide/guide.pdf. at http://www.cdc.gov/phpr/capabilities/DSLR_capabilities_July.pdf. 69. US Department of Labor. Toxic and hazardous substances: hazard 49. Mind Tools Ltd. Active listening. Hear what people are really saying. communication (OSHA 29 CFR 1910.1200 [Final Rule]). Washington, Wiltshire, UK: Mind Tools Ltd. Available at http://www.mindtools. DC: US Department of Labor, Occupational Safety and Health com/CommSkll/ActiveListening.htm. Administration; 2013. Available at http://www.osha.gov/pls/oshaweb/ 50. 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Fleming DO, Hunt D. Biological safety: principles and practices. 4th brave new world of consolidated and shared IT services: a guide for ed. Washington, DC: ASM Press; 2006. laboratories. Silver Spring, MD: Association of Public Health Laboratories; 65. Heymann DL. Control of communicable diseases manual. 19th ed. 2011. Available at http://www.aphl.org/AboutAPHL/publications/ Washington, DC: American Public Health Association; 2008. Documents/COM_2011_ITConsolidatedandSharedServices.pdf. 66. International Air Transport Association. Dangerous goods regulations. 81. O’Carroll PW; Public Health Informatics Competencies Working Group. 56th edition requirements. IATA; 2015. Available at http://www.iata. Informatics competencies for public health professionals. Seattle, WA: org/whatwedo/cargo/dgr/pages/download.aspx. Northwest Center for Public Health Practice, University of Washington 67. International Organization for Standardization. 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82. Murray PR. Manual of clinical microbiology. 6th ed. Washington, DC: ASM Press; 1995. 83. National Research Council (US) Committee on Prudent Practices in the Laboratory. Prudent practices in the laboratory: handling and management of chemical hazards, updated version. Washington, DC: National Academies Press; 2011. Available at http://www.ncbi.nlm.nih. gov/books/NBK55878. 84. National Center for Biotechnology Information, US National Library of Medicine. Welcome to NCBI. Bethesda, MD: National Library of Medicine; 2009. Available at http://www.ncbi.nlm.nih.gov. 85. Welch L, Lewitter F, Schwartz R, et al. Bioinformatics curriculum guidelines: toward a definition of core competencies. PLoS Comput Biol 2014;10:e1003496. 86. National Postdoctoral Association. The NPA postdoctoral core competencies toolkit. New York, NY: National Postdoctoral Association; 2009. Available at http://www.nationalpostdoc.org/competencies. 87. Steneck NH/CDC Office of Research Integrity. Introduction to the responsible conduct of research. Washington, DC: US Department of Health and Human Services; 2007. Available at http://ori.hhs.gov/sites/ default/files/rcrintro.pdf.
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Appendix A
Public Health Laboratory Proficiency Tier Definitions Proficiency tier Definition* Beginner A beginner worker is one who can demonstrate an elementary level of performance. Beginners might have gained enough classroom or on-the-job training to note (or to have pointed out to them by a mentor) recurring principles and themes but might not yet be able to apply them consistently. The beginner worker might have sufficient subject matter knowledge, but has limited experiential knowledge needed to perform a task, behavior, or function without frequent guidance or oversight.
Competent A competent professional is one who has been in the same or similar job and who begins to see their actions within the context of the laboratory’s long-range goals and plans. The competent laboratory scientist is developing knowledge and experience to recognize a situation in terms of an overall picture or in terms of which aspects are most salient or most important. The competent worker has the necessary ability to cope with and address many contingencies of laboratory operations, as this person has a feeling of adequacy and is able to perform a task, behavior, or function with a high degree of independence.
Proficient A proficient laboratory professional understands situations as a whole and perceives their meaning in terms of the laboratory’s mission and long-term goals. The proficient person learns from experience what typical events to expect in a given situation and how plans need to be modified in response to these events. The proficient laboratory scientist uses established principles to manage the many contingencies of laboratory operations and has developed sufficient mastery to integrate or design a new task, behavior, or function.
Expert The expert laboratory scientist, with substantial experience and knowledge, has an intuitive grasp of situations and focuses on the root of the problem. The expert operates from a deep understanding of the total situation and integrates systems thinking, collaborative relationships, and the resources at their disposal to achieve the laboratory’s mission. The expert laboratory scientist has acquired mastery to design new strategies, policies, tasks, behaviors, and functions that support quality operations.
Sources: Benner, P. From novice to expert: promoting excellence and power in clinical nursing practice. Menlo Park, CA: Addison-Wesley; 1984. Dreyfus SE, Dreyfus HL. A five-stage model of the mental activities involved in directed skill acquisition. Berkeley, CA: University of California–Berkeley; 1980. * Definitions were developed by two CDC/APHL Steering Committee members by adopting Dreyfus’s Model of Skill Acquisition and modifying Benner’s Stages of Clinical Competence. Tiers do not correspond directly to grade levels or job titles.
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Appendix B Terms Used in These Guidelines
Accounts receivable: the tracking of payments owed to the select agents and toxins, and controlled chemicals and other laboratory from the provision of goods and services, and the chemical materials). management of invoices generated for clients and other customers. Automated identification system: an automated, computerized Accreditation: the process by which an authoritative body system developed for the identification of bacteria and gives formal recognition that an organization is competent to yeasts in clinical and nonclinical samples. Such systems can carry out specific tasks. be semi-automated or fully automated. Examples include Active listening: a communication technique in which biochemical methods, nucleic acid amplification tests (NAAT), a listener is attentive and empathetic, accepts the speaker’s antimicrobial susceptibility testing panels, high-performance message without judgment, asks questions, and restates or liquid chromatography (HPLC), and mass spectrometry. paraphrases the speaker’s message to get all the information Automated susceptibility testing system: an automated, needed to make a decision and to ensure full comprehension computerized system developed for the detection of the by both parties. sensitivity of organisms to one or more antimicrobial agents. Administrative controls: measures concerning work Basic scientific and laboratory concepts and theories: procedures such as written safety policies, work practices, rules, concepts and theories applied by staff during the performance supervision, schedules, and training with the goal of reducing of sample analyses. Examples include the effects of temperature the duration, frequency, and severity of exposures to hazardous on samples and organisms; the principles of acids, bases, materials or situations. and pH; molarity; accuracy and precision; sensitivity and After Action Review (AAR): a structured activity or de-brief specificity; the different wavelengths of light (and uses in the process for analyzing what happened, why it happened, and laboratory); the concepts behind different kinds of microscopy; how it can be done better. the science behind distillation, filtration, extraction, and Agent-specific antigen detection: methods designed to test chromatography; and the principles of polymerase chain for specific antigens of microbial agents (e.g., bacteria, fungi, reaction (PCR), sequencing, enzyme-linked immunosorbent parasites, viruses) or for microbial antigen-specific antibodies. assay (ELISA) and other techniques. Testing might be performed using enzyme immunoassays (EIA) Batch: a sequenced grouping of both test samples and all or immunofluorescent assays for direct detection of the antigen associated quality control samples required by a testing method. in a clinical sample or for identification of a given agent after Biohazardous materials: infectious agents or hazardous it has been cultivated. biological materials that present a risk or potential risk to the Alternative assessment: a system for determining the health of humans, animals, or the environment. The risk can reliability of tests for which proficiency testing is either not be direct through infection or indirect through damage to the available or not required. Appropriate alternative assessment environment. Biohazardous materials include certain types procedures might include split-sample analysis with reference of recombinant DNA; organisms and viruses infectious to or other laboratories; split-sample analysis with an established humans, animals, or plants (e.g., parasites, viruses, bacteria, in-house method; analysis using assayed materials or regional fungi, prions, and rickettsia); and biologically active agents pools; clinical validation by chart review; or other suitable (e.g., toxins, allergens, and venoms) that can cause disease in and documented means. Alternative assessment may also be living organisms or cause significant impact to the environment considered performance testing. or community. Assessment: a systematic process of collecting and analyzing Biological materials: any biologically derived materials or data to determine the current, historical, or projected condition materials that contain biological species (e.g., microorganisms, of an organization, process, or activity; also referred to as genetically modified organisms or microorganisms, viruses, inspection or survey. or prions). These materials are not necessarily pathogenic or Assessment rubric: a scoring tool that explicitly represents the hazardous. Examples include, but are not limited to, cellular performance expectations for an assignment or piece of work. lines, DNA materials, tissues, organs, body fluids, cultured Assets: the resources of an organization or facility (e.g., cells, allergens, and select agents and toxins. staff, equipment, instruments, computers, materials including
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Biosecurity: the discipline addressing the security of Chemical concepts: basic concepts and theories related to biological agents and toxins and the threats posed to human chemicals and their characteristics that staff should be able to and animal health, the environment, and the economy by apply in performing their job responsibilities. Examples include misuse or release. It includes the protection of microbial the principles of acids, bases, and pH; the theories underlying agents, biological materials, and research-related information distillation, filtration, extraction, and chromatography; from unauthorized possession, loss, theft, misuse, diversion, optical techniques; enzymes and rate analysis; principles of or intentional release. immunochemical techniques; principles of molecular biology; Budgeting: the process of developing plans for the and the types of environmental media (e.g., water, soil, food, laboratory’s anticipated income and expenditures. and animal feed) and the chemicals commonly found in each. Capital budgeting: the process of planning funding for Chemical hygiene plan: a written program developed and long-lived assets such as equipment and buildings. implemented by the organization that outlines procedures, Category A infectious substance: an infectious substance equipment, personal protective equipment, and work practices that is transported in a form that is capable of causing that are capable of protecting staff from the health hazards permanent disability or life-threatening or fatal disease to presented by hazardous chemicals used in that particular otherwise healthy humans or animals when exposure to the workplace and that complies with Occupational Safety and substance occurs. Examples include Bacillus anthracis (cultures Health Administration (OSHA) regulations. only), Clostridium botulinum (cultures only), Hepatitis B Chemical materials: substances with a distinct molecular virus (cultures only), West Nile virus (cultures only), and composition that are produced by, or used in, chemical hemorrhagic fever-causing viruses such as the Ebola and Lassa processes. Chemicals can be present in the laboratory as solids, viruses (in any form). liquids, mists, vapors, or gases. Category B infectious substance: an infectious substance not Coaching: a specific behavior modification technique to improve transported in a form generally capable of causing permanent another person’s performance quantitatively and qualitatively. disability or life-threatening or fatal disease in otherwise healthy Communication methods: methods that include in-person humans or animals when exposure to the substance occurs. and virtual meetings, phone calls, and electronic methods (e.g., This includes Category B infectious substances transported e-mail, social media, podcasts, and webinars). for diagnostic or investigational purposes. Examples include Communication technology: the means by which Vibrio cholera, Hepatitis A virus, Epsilon toxin of Clostridium information is exchanged between persons through the perfringens, and food safety threats such as Salmonella species application of technical processes, methods, or knowledge (e.g., and Campylobacter jejuni. the use of e-mail, web-based presentations, or social media). Certification: a process by which a third party gives written Computer science domains: subfields of computer science that assurance that a service or person conforms to specified requirements. can be directly applied to biological problems such as artificial Chain of custody: procedures and the unbroken chain of intelligence, image processing, pattern recognition, data mining, documentation that account for the integrity of an item of knowledge representation, and natural language processing. evidence by tracking its movement, location, and possession Confidentiality: a principle regarding the preservation from its point of collection to its final disposition. of authorized restrictions on the access and disclosure of Change control: 1) a structured method of revising any information, including means for protecting personal privacy policy, process, or procedure; 2) a process for implementing and proprietary information. However, “confidentiality” is not changes to software or other information technology (IT) synonymous with “privacy” (the right of a person to keep his solutions using a coordinated approach. or her information private). Change management: a process to support moving from a Confidentiality, Integrity, and Availability (CIA): a current state through a transition state to a future state. From compound term that refers to the following three elements: a process perspective, it is a structured method of revising • Confidentiality: preserving authorized restrictions on the any policy, process, or procedure (also referred to as Change access and disclosure of information, including means for Control). This includes activities such as transition planning protecting personal privacy and proprietary information; and the design of hardware and software. It also includes • Integrity: guarding against improper information revisions to all associated documents and records. From modification or destruction, and includes ensuring information a personnel perspective, it is an approach to transitioning nonrepudiation and authenticity; persons, teams, and organizations to a desired future state. • Availability: ensuring timely and reliable access to, and use of, information.
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Continuity of Operations Plan (COOP): a strategic plan Data structure: an organized form, such as an array list or that details how essential functions of an agency will be handled string, in which connected data items are held in a computer. during a wide range of emergencies or situations that might Decontamination: the process of reducing or eliminating disrupt normal operations, including localized acts of nature, biologic, radioactive, or chemical agents from a surface or accidents, and technological or attack-related emergencies. space. Decontamination includes disinfection and sterilization. Continuous Quality Improvement (CQI): a recurring Diversity: the inclusion of different types of persons in a activity to increase the ability to fulfill quality requirements. group or organization. Differing elements or qualities might CQI includes the actions taken throughout an organization include race, ethnicity, sex, sexual orientation, socioeconomic to increase the effectiveness and efficiency of activities and status, age, physical abilities, religious beliefs, political beliefs, processes in order to provide added benefits to the customer or other ideologies. and organization. Documents: paper-based or electronic media that Contract: a legally binding agreement between two parties communicate information. Generally, documents need to be for the purpose of obtaining goods or services. Contracts often updated periodically and require revision control. contain specific obligations for both payor and recipient; and, eLearning: learning that utilizes electronic technologies there is usually significant programmatic involvement by the to access training and educational curriculum outside of a payor during the performance of the activities. Typically, traditional classroom. In many cases, it refers to a course, dollars are drawn down as services defined in the agreement program or degree delivered completely online, though delivery are performed. can also include videotape, DVD, and interactive television. Contractual instruments: documents that include Service Electronic laboratory reporting (ELR): the automated Level Agreements (SLA), memoranda of understanding transmission of laboratory-related data from commercial, (MOU), memoranda of agreement (MOA), contracts with IT public health, hospital, and other laboratories to state and local and other vendors, and data exchange agreements with data public health departments through an electronic health records exchange partners. (EHR) system or a Laboratory Information Management Control measures: methods used to eliminate or reduce the System (LIMS). potential for exposure to a hazard. Emergency alarm: a piece of equipment and/or device Corrective action: action that eliminates the cause(s) of a designed to inform staff that an emergency exists or to signal detected nonconforming event or other undesirable situation. the presence of a hazard requiring urgent attention. Corrective action is taken to prevent recurrence, whereas Emergency communication plan: a plan that is used during preventive action is taken to prevent occurrence. the response and recovery phases of an emergency or surge Cost of quality: the total of the tangible and intangible costs event to effectively and efficiently communicate with all staff incurred by investing in the prevention of nonconforming internally and with emergency response personnel and the events according to requirements, appraising a product or public externally. service for conformance to requirements, and reworking Emergency preparedness and response networks: federal, products or services to conform to requirements. state, and local networks that collaborate to provide emergency Critical surveillance event: a situation in which there is preparedness and response capabilities. Such networks include, an active surveillance system for a specified reason and period but are not limited to, the National Incident Management usually initiating an urgent and highly-controlled systematic System (NIMS) and the Integrated Consortium of Laboratory process. There is a significant need for use of staff and resources to Networks (ICLN), which comprises the Laboratory Response support the determination of the agent at the center of the event. Network for biological threats (LRN-B), the Laboratory Critical thinking: the thought processes used to Response Network for chemical threats (LRN-C), the Food conceptualize and evaluate information, and to the practice Emergency Response Network (FERN), the National Animal of using conclusions to guide individual and organizational Health Laboratory Network (NAHLN), the National Plant behavior. Critical thinking involves clarifying goals, examining Diagnostic Network (NPDN), the Environmental Response assumptions, discerning hidden values, evaluating evidence, Laboratory Network (ERLN), and the U.S. Department of and assessing conclusions. Defense Laboratory Network (DLN). Customer: an organization or person that receives a product or Emergency response plan: a written plan that details service. Examples include consumers, clients, end users, retailers, step-by-step procedures to follow in emergencies such as fire, beneficiary purchasers, patients, and health-care providers. external chemical spills, or a major accident. An emergency A customer can be internal or external to the organization. response plan also includes information such as whom to notify, Laboratory staff may be regarded as internal customers. who should do what, and the location of emergency stocks.
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Engineering controls: methods to remove a hazard Exposure prevention: a process that involves evaluating or to place a protective barrier between the worker and the incident response procedures to ensure that actions taken the workplace hazard, which usually involves specialized during the response do not result in hazardous exposures. equipment and elements of building design. Examples include External assessment: a system to ensure compliance, safety equipment (e.g., biosafety cabinets), facility egress, and competency, accuracy and precision of test system components, directional airflow. environment, and operator performance through evaluation Environmental controls: the conditions within a laboratory by external groups or comparison using external samples. facility that accommodate the correct performance of Examples include external audits and proficiency testing. laboratory testing. Examples of environmental controls are Federal Select Agent Program: a program that oversees lighting, humidity, temperature, and floor space clearance. the possession, use, and transfer of biological select agents Equal Employment Opportunity (EEO): policies and and toxins. It comprises staff from CDC’s Division of Select practices in employment and other areas that prohibit Agents and Toxins and the Animal and Plant Health Inspection discrimination against an applicant or employee on the basis Service/Agricultural Select Agent Services. of race, color, sex (including pregnancy), age, religion, national Formative assessment: the gathering of information or origin, mental or physical disability, or genetic information. data about a training course or program that is used to guide Equipment qualification plan: a plan that addresses improvements in teaching and learning. Formative assessment the three steps of laboratory equipment qualification (i.e., takes place before the training implementation and includes installation qualification, operational qualification, and such activities as pilot-testing. performance qualification). Laboratory staff must perform Good housekeeping procedures; procedures related to the the equipment performance qualification, and the equipment maintenance and management of the facilities, property, and manufacturer may perform the installation qualification and equipment of an institution. Good housekeeping procedures operational qualification. prevent accidents and reduce the risk of harmful exposures to Ethical conduct in research: the application of rules all laboratory and service staff. and professional codes of conduct that promote the aims of Grant: a legally binding agreement between two parties research, encourage essential collaborations, ensure researchers usually for the purpose of transferring money, property, are accountable and promote moral and social values. These or services to a recipient, though it can also be used to principles include honesty in conducting and reporting research, procure products or services. Grants usually involve minimal objectivity, integrity, carefulness, openness, respect for intellectual programmatic involvement by the grantor. Typically, monies property, confidentiality, responsible authorship and peer review, are given in a lump sum at the start of the agreement or social responsibility, nondiscrimination, competence, legality, according to a set disbursement schedule. animal welfare, and protection of human subjects. Hazardous chemical: any chemical which is classified as Ethical practices: values and standards such as personal a health hazard or simple asphyxiant in accordance with the accountability and credibility, honesty, fairness, forthrightness, Occupational Safety and Health Administration’s (OSHA) striving for excellence, transparency, impartiality, respect Hazard Communication Standard. for colleagues and partners, relationship building, diversity Hazard communication: a written program that conveys and inclusiveness, social responsibility, environmental information concerning hazards. Hazard communication responsibility, upholding privacy and confidentiality, and includes, but is not limited to, use of safety signage, Safety Data adhering to policies regarding conflict of interest. Sheets (SDS), and other written sources describing hazards of Examination (analytical phase): a set of operations a material or space. (analyses) having the objective of determining the value or Hazard control: methods used to eliminate or reduce the characteristics of a property or sample, ending when the potential for exposures to a hazard. postexamination phase begins. Hazardous material alert: an alert triggered by use of a Exposure event: a specified set of conditions in which a person hazardous material or safety equipment that requires either a or group is subject to a harmful substance that is a potential cause notification (e.g., a label or signage) and/or a response (e.g., of disease or an altered health state (e.g., a laboratory accident clean up or safety precaution). occurs causing workers to be exposed to radiation). Hazardous materials: solids, liquids, gases, or radioactive Exposure monitoring: a record of any measurements taken substances that can harm persons, other living organisms, to monitor staff exposures and any medical consultation and property, or the environment. examinations (including tests or written opinions). Hazardous spill: a breach of a substance from its container (e.g., can, jar, drum, vessel, or pipe) in some fashion in the
86 MMWR / May 15, 2015 / Vol. 64 / No. 1 Supplement environment or community that results in exposure to high of learning needs and goals and the development of a delivery concentrations of toxic substances; situations that are life or system to meet those needs. injury threatening; imminent danger to life and health (IDLH) Integration engine is software that works as a go-between environments; situations that present an oxygen deficient for different systems. atmosphere; conditions that pose fire or explosion hazards; Internal audit: an activity carried out by laboratory staff that situations that require evacuation of the area; and/or situations verifies laboratory operations adhere to the requirements of the that require immediate attention because of the danger posed to management system, the customer, and/or regulatory agencies. persons in the area. The properties of the hazardous substance, Inventory record: a record that tracks the quantity, the circumstances of the release, and the mitigating factors in form, location, and disposition of any biologic, chemical, the work area combine to define the distinction between a or radiological material in use, stored, or disposed of in a release requiring an emergency response and one that does not. laboratory. Incident: an unexpected event that causes or has the Knowledge management (KM): the process of organizing, potential to cause loss, injury, illness, unsafe conditions, or accessing, and leveraging a laboratory’s intellectual resources disruptions to normal procedures. and information systems to generate value-added benefits Incident Command System (ICS): a standardized, on-scene, internal and external to the laboratory. all-hazards incident management approach that allows for Laboratory-developed test (LDT): an in vitro device (IVD) the integration of facilities, equipment, staff, procedures and that is intended for clinical use and designed, manufactured, communications that operate within a common organizational and used within a single laboratory. LDTs are not approved structure; enables a coordinated response among various or cleared by the U.S. Food and Drug Administration (FDA). jurisdictions and functional agencies, both public and private; and Laboratory equipment: the wide array of manual and establishes common processes for planning and managing resources. automated machines (including instrumentation) used to Incident response plan: a written program that identifies perform sample preparation and analyses. This includes simple how staff should react to incidents and other emergencies at equipment (e.g., incubators, centrifuges, balances, water baths) their facility. and complex equipment (e.g., PCR machines, sequencers, Information: knowledge derived from study, experience, mass spectrometers, multi-channel analyzers, ELISA readers). instruction, communication, intelligence, or news. It includes Laboratory facility: the physical spaces within a public resources and materials that are created and distributed, health laboratory building, including office spaces; meeting including graphs or charts. Information also includes and conference rooms; areas where food is stored, prepared, knowledge of specific events or situations that has been or eaten; and areas where pre-examination, examination, and gathered or received. postexamination testing activities are performed. This also Information security: the protection of information and includes areas where laboratory supplies and reagents are stored, information systems from unauthorized access, use, disclosure, prepared, cleaned, and sterilized. disruption, modification, or destruction in order to provide Laboratory Information Management System (LIMS): confidentiality, integrity, and availability (CIA). Information a collection of software/computerized methods that offers a security measures include backup systems, passwords, and set of critical features that support a laboratory’s operations, shredding of sensitive information before disposal. including the acquisition, analysis, storage, and reporting of Institutional safety committee: a group comprising a cross- laboratory data. A LIMS is a highly configurable application section of staff members and other stakeholders with the goal that is customized to facilitate a wide variety of models for of establishing or monitoring work practices to ensure worker laboratory testing workflow. Sometimes referred to as LIS safety, compliance, and awareness with regard to a specific or (Laboratory Information System). general workplace hazard. Examples include local committees Laboratory program: an organizational activity (e.g., quality such as the safety committee, radiation safety committee, assurance, safety, system improvement, training) or component institutional animal care and use committee, institutional that covers a major laboratory discipline (e.g., environmental review board, and environmental programs advisory panel. chemistry, public health microbiology, newborn screening, Instructional design: the systematic development of environmental microbiology, molecular biology), which might instructional specifications using learning and instructional include more than one laboratory section. theory to maximize the quality of instruction, making the Learning environment: the physical and emotional states acquisition of knowledge and skill more efficient, effective, and that the learner brings to the learning endeavor, as well as the appealing. Instructional design is the entire process of analysis social setting that the student finds in the learning space.
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Legacy data system: an old or outmoded system being Mentoring: a developmental partnership between a staff maintained because it contains historical data or other useful member and a subject matter expert for the purposes of business intelligence. sharing technical information, institutional knowledge, and Licensing: a documented approval process usually granted insight with respect to a particular occupation, profession, by governments (federal or state) to entities such as hospitals, organization, or endeavor. Typically, a mentor is a more laboratories, and persons to conduct a specific scope of experienced and knowledgeable person providing guidance to activities within relevant jurisdictions. a mentee who is a less experienced and knowledgeable person. Licensure: the official “permission to practice” for staff of Message type: the kind of a message communicated between defined occupations and professions. Licensure is often granted systems that specifies its name, structure, and content data type. through a professional body or regulatory agency comprising Microbiological concepts and theories: concepts and advanced practitioners who oversee the applications for licenses. theories that relate to characteristics of microorganisms This often involves accredited training and examinations, but and infectious agents that staff should be able to apply in varies a great deal for different activities. performing their job responsibilities. Examples include Lifecycle management strategy: the continuous process of taxonomy, pathogenic versus nonpathogenic microorganisms, managing the laboratory’s IT investments and its procedures incubation period, containment, principles of microbial for testing, modifying, and implementing changes to existing culture, detection limits, antimicrobial susceptibility, and computing systems, including hardware, software, documentation, medium and mode of disease transmission. and installing new systems throughout the lifecycle. Model laboratory practices: activities and processes integral Logical structure: an introduction, supporting information, to the provision of laboratory testing services that optimize and conclusion. the quality of the result. These practices are guided by certain Manual identification methods: various biochemical tests industry standards and are adopted by a laboratory to maximize that are manually performed and used to identify bacteria, safety, effectiveness, efficiency, timeliness, and public health/ yeast and fungi. These tests may be performed either singly, community outcomes. These practices are usually independent such as spot tests or tube biochemicals (e.g., catalase, oxidase, of the test or measurement techniques employed and are not indole, Triple Sugar Iron [TSI], or motility), or combined into to be confused with U.S. Food and Drug Administration multiple panels distributed commercially as strips or cards. regulations on Good Laboratory Practice (FDA regulation 21 Manual susceptibility testing methods: various materials CFR 58). In the recent past, these practices were referred to as containing specific concentrations of antibiotics that are “best practices,” but it is now acknowledged that there is not manually applied to media that has been plated with a specific one collection of best practices for each laboratory or situation. concentration of an organism. The presence or absence of Module: a software component that is part of a larger growth around the antibiotic disc or strip after incubation is enterprise software system and performs a specific, independent, measured and interpreted to determine the susceptibility of the and interchangeable function of the larger system. organism to the antibiotic. Examples include the Kirby-Bauer Nonconforming event (NCE): an event that does not fulfill a method and Epsilometer test (E-test). requirement. Other terms frequently used include accident, adverse Master record: a record containing a comprehensive profile event, discrepancy, error, incident, nonconformity, and occurrence. and other details about a person, material, or organization Notifiable result: a result generated by a laboratory from a associated with the laboratory. sample related to an infectious disease or organism, hazardous Medical surveillance program: the ongoing, systematic agent, or condition that when identified by a laboratory, must collection of health data that signal either biomarkers of be reported by the laboratory to specified public health entities exposure or early signs of adverse health outcomes from known as set forth under local, state, and/or federal law. biologic, chemical, and radiological materials and toxicants in Occupational Safety and Health Administration (OSHA): persons working with those materials. This includes a program the chief federal agency charged with the enforcement of safety for pre-employment screening, ongoing monitoring, and and health legislation. postexposure management. Outbreak: the occurrence of more cases of disease, injury, Memoranda of agreement (MOA): documents describing or other health condition than expected in a given area or in detail the specific responsibilities of, and actions to be taken among a specific group of persons during a specific period. by, specific parties so that goals might be accomplished. Usually, the cases are presumed to have a common cause or to Memoranda of understanding (MOU): documents that be related to one another in some way. Sometimes the cases describe broad concepts of mutual understanding, goals, and are distinguished from an epidemic as being more localized. plans shared by parties.
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Personal hygiene procedures: practices performed by barriers, sign-in logs, and security guards, designed to protect persons that serve to promote or preserve health when and safeguard the physical components of a facility, including working in the laboratory. Examples include washing hands staff and other assets. after working with potentially hazardous materials and before Plain talk: nontechnical communication that does not leaving the laboratory; not eating, drinking, smoking, handling use technical jargon or field-specific language. The speaker contact lenses, applying cosmetics, or storing food for human or writer conveys the meaning of the communication clearly consumption in the laboratory; and not mouth pipetting. and simply so that the information is easily understood. Also Personal protective equipment (PPE): items worn by referred to as “plain language.” laboratory workers to prevent direct exposure to hazardous Policy: a set of basic principles or guidelines to direct plans, materials. Examples include gloves, gowns, aprons, laboratory actions, and decisions of staff and the organization. coats, containment suits, shoe covers, eye and face shields, Postexamination (postanalytical phase): processes respirators, and masks. following examination (sample analysis) that include systematic Personnel security concepts: activities pursued in an review, formatting, and interpretation; authorization for attempt to evaluate a person’s suitability for a given position. release; and reporting and transmission of the results. This Typical personnel security concepts include verifying identity phase also includes storage of samples that have undergone and personal information, professional information (e.g., laboratory analysis. previous employment and education), a person’s character Pre-examination (pre-analytical phase): processes starting (e.g., through checking references), and a person’s suitability for with, in chronological order, the submitter’s test order and particular job responsibilities (e.g., through checking criminal including: the examination (analysis) requisition; preparation records, court records, and credit reports). of the patient (if applicable); collection of the primary sample; Personnel security program: a system for addressing and transportation to and within the laboratory, ending when insider threats to ensure that only trusted persons are given the examination (analytical) phase begins. authorized access to restricted areas. The program includes Preventive action: action that eliminates the cause(s) of a policies and procedures to ensure that persons that work potential nonconforming event or any other potential undesirable within an organization are trustworthy and competent to situation. Preventive action is taken to prevent occurrence, whereas carry out an organization’s mission. This includes conducting corrective action is taken to prevent recurrence. interviews of applicants, evaluating positions, and verifying Procedure: a specified way to carry out an activity of a process. applicant suitability (e.g., through a National Agency Check Process: a set of interrelated or interacting activities to with Inquiries [NACI] and special background investigations). achieve a particular end. Physical hazards: unsafe conditions in the workplace Process improvement indicators: measures that track that can cause injury or illness. Examples include ergonomic results and efficiencies gained in a laboratory following the hazards; electrical shock hazards; loud noises; slip, trip, and fall modification of laboratory testing business processes. hazards; exposure to hot and cold temperatures; compressed gas Process management: activities that directly or indirectly cylinders; and sharps (i.e., items capable of cutting or piercing relate to the laboratory’s path of workflow to optimize human skin such as hypodermic needles, syringes [with or effectiveness and efficiency. without attached needles], Pasteur pipettes, scalpel blades, Proficiency testing: an evaluation of the laboratory’s suture needles, blood vials, needles with attached tubing, performance on analysis of samples of external origin for the and culture dishes [regardless of the presence of infectious purposes of determining adequacy of the laboratory’s pre- agents]; and other types of broken or unbroken glassware [e.g., examination, examination, and postexamination activities. microscope slides and cover slips]). Project management: the practice of planning and Physical security access controls: restrictions that provide managing laboratory projects to ensure that they stay within reasonable assurance that only authorized staff are allowed to scope, time, quality, and cost limits. enter a restricted area. The type of access controls depends on Project management concepts: principles regarding the the level of security required (e.g., something one has [such as management of projects that include controlling the process, a physical or electronic key], something one knows [such as meeting management, time management, scheduling, a PIN number], or some natural/innate characteristic or trait managing resources, and team building. [i.e., one that can be detected by biometric devices]). Protected information: any information about a person that Physical security infrastructure: the aggregate collection is maintained by an organization that relates to issues of privacy of physical elements, such as locks, access controls, alarms, (the right of a person to keep his or her information private) closed-circuit television monitoring systems, fences and other
MMWR / May 15, 2015 / Vol. 64 / No. 1 89 Supplement and confidentiality (ensuring that information is accessible Quality management system (QMS): coordinated activities only to those authorized to have access). Protected information to direct and control an organization with regard to quality. includes any information that can be used to distinguish or In a QMS, all aspects of the laboratory operation, including trace a person‘s identity and any other personal, health, or the organizational structure, processes and procedures, need medical information that is linked or linkable to a person. to be addressed to ensure quality. Notable regulations include the Health Insurance Portability Radiation monitoring device: a scientific determination and Accountability Act of 1996 (HIPAA) Privacy Rule, which of amount, rate, and distribution of radiation emitted from a governs the protection, use, and disclosure of individually source of ionizing radiation. An example is a Geiger counter. identifiable health information, and the HIPAA Security Rule, Radiological materials: radioisotopes, radioactive waste which governs the security of certain health information that products, and chemical or biological materials that have been is held or transferred in electronic form. modified to include radioisotope labels. Protocol: 1) a detailed plan for conducting a scientific Records: evidence of results achieved or activities performed. procedure; 2) a set of technical rules for the transmission and Records can be used, for example, to demonstrate traceability and receipt of information between computers. to provide evidence of verification, preventive action, or corrective Quality: the degree to which a set of inherent characteristics action. Generally, records need not be under revision control. fulfills requirements. Reflex testing: follow-up testing when initial test results Quality assessment: a means to determine the quality of are positive or outside normal parameters and indicate that the results generated by the laboratory. It is usually an external additional, related testing is clinically appropriate. evaluation of the laboratory’s performance. Quality assessment Regulated waste: liquid or semi-liquid blood or other is a challenge to the effectiveness of the quality assurance and potentially infectious materials, contaminated items that would quality control programs and can be described as a system of release blood or other potentially infectious materials in a liquid procedures, checks, and audits to judge and control the quality or semi-liquid state if compressed, items that are caked with dried of measurements and reduce the uncertainty of data. blood or other potentially infectious materials and are capable of Quality assurance (QA): planned and systematic activities releasing these materials during handling, contaminated sharps, implemented in a quality system so that quality requirements and pathological and microbiological wastes containing blood and goals for a product, service, or activity will be fulfilled. or other potentially infectious materials. From a quality-improvement viewpoint, it is a system for Requirement: a condition or capability needed to achieve an ensuring a desired level of quality in the development, objective that must be met or possessed by a system or system production, or delivery of products and services. From a bench- component to satisfy a standard or specification. level viewpoint, it is the practice of assessing performance in all Research animal: any live animal used or intended for use in steps of the laboratory testing cycle including pre-analytical, research, research training, experimentation, biological testing analytical, and postanalytical phases to promote excellent or for related purposes. Examples include mice and rats. When outcomes in public health. evaluating hazards of research animals, staff should consider Quality control (QC): an integral component of quality the risks inherent to the species itself, those associated with assurance and is the aggregate of processes and techniques to handling the animals (e.g., bites, scratches, and allergens), detect, reduce, and correct deficiencies in an analytical process. and the risks associated with handling the bedding and other It also refers to the measures that must be included during each associated waste products. assay to verify that a test is working properly. Risk assessment (risk analysis): 1) the process of identifying Quality control (QC) data: QC measures intended to reflect risks to organizational assets (including staff) and operations the quality of laboratory testing processes and the accuracy, (including mission, functions, image, and reputation); includes precision, and reliability of the test results. threat and vulnerability analyses and is the fundamental tool to Quality indicators: observations, statistics, or data defined help select the right risk mitigation measures (e.g., engineered by the organization or service that typify the performance of a controls, standard policies and procedures) to achieve an given work process and provide evidence that the organization acceptable level of security; 2) the evaluation of the probability or service is meeting its quality intentions. Quality indicators and consequences of exposure to a given hazard, with the are also referred to as “key performance indicators” or “quality intent to reduce the risk by establishing the appropriate hazard metrics,” and might be reported in various formats such as a controls to be used. “dashboard” or “scorecard.”
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Risk communication: a style of communication used to and peer review, adhering to intellectual property laws, and exchange information and establish effective dialogue during adhering to chain of custody rules and policies. emergency or highly sensitive situations by those responsible Scientific integrity: principles and standards such as validity, for assessing, minimizing, and regulating risk to those who verification, and appropriateness. It also includes data integrity, might be affected by the outcomes of those risks. by which information produced and results reported are whole, Risk mitigation plan: an evaluation of threats, vulnerabilities, complete, and accurate; are obtained using proper methods; and consequences based on a site-specific risk assessment. and are not altered by any unauthorized additions, deletions, Root cause analysis: a process for identifying the basic or or modifications. causal factor(s) that underlie variation in performance, including Security concepts: aspects critical to the management of the occurrence or possible occurrence of a nonconforming event. the security of an organization (including staff and other Route of exposure: the path by which humans or other assets) and its activities. These concepts include assurance living organisms come into contact with a hazardous substance. (that a security system will behave as expected), risks, threats, Examples include breathing (inhalation), eating or drinking countermeasures, vulnerability, exploits, and defense in depth (ingestion), and contact with skin (dermal absorption). (relying on multiple security measures). Safety Data Sheet (SDS): a fact sheet that summarizes: Security plan: a formal document that provides the information regarding material identification for a chemical systematic design for implementing an organization’s security product or mixture, including hazardous ingredients; health, goals. It is a blueprint for how an organization secures its assets. physical, and fire hazards and the necessary or suggested It establishes the performance goals for the system and metrics first aid procedures to employ; chemical reactivities and for performance. Security plans are designed according to a incompatibilities; spill, leak, and disposal procedures; and site-specific risk assessment. protective measures required for safe handling and storage. Segregated waste categorization: the procedures for Safety program: the general safety, biosafety, biosecurity, categorizing, segregating, color-coding, storing, transporting, chemical, radiological, and emergency plans of an institution and tracking laboratory waste. that all staff are required to follow in order to manage Select agents: a subset of biological agents and toxins that possible workplace hazards. The safety program also includes the U.S. Departments of Health and Human Services (HHS) policies related to staffing, organizing safety committees, and and Agriculture (USDA) have determined to have the potential conducting safety assessments. to pose a severe threat to public health and safety, to animal or Safety signage: a mechanism to communicate information plant health, or to animal or plant products. The Select Agent related to hazards of a material or space. Examples include Regulations are contained in 42 CFR Part 73, 9 CFR Part 121, pictograms, container labels, and other posted signs. and 7 CFR Part 331. Sample: a small part of, or a selection from, something Sensitive information: privileged or proprietary information intended to show the quality, style, or nature of the whole. which, if compromised through alteration, corruption, loss, In all domains of this competency set, “sample” is meant to misuse, or unauthorized disclosure, could cause serious harm include clinical and nonclinical samples and specimens. to the organization owning it. Sensitive information, which Sample appropriateness: the physical, chemical, and includes protected information, can only be released to the biological characteristics of a sample that are necessary to yield subject of the information and to those who have a legitimate accurate and representative test results. need to know, to outside entities with the subject’s written Sample lifecycle: a comprehensive description of all sample permission, and to others as allowed by law. In many cases, the processes, sample management, transfers, and data collection, use of this information is protected by either state or federal law. with their corresponding LIMS actions throughout the period Service level agreement (SLA): a contractual agreement the laboratory interacts with the sample. between an internal or external service provider and the Sample management: the collection, handling, labeling, customer that specifies performance guarantees with associated packaging, shipping, transport, accessioning, receipt, tracking, penalties should the service not be performed as contracted. evaluation (including testing for sample appropriateness), and Sharps: items capable of cutting or piercing human skin. storage of clinical and nonclinical samples or specimens. Examples include hypodermic needles, syringes (with or Scientific ethics: principles, rules, and standards guiding the without attached needles), Pasteur pipettes, scalpel blades, performance of persons and the conduct of laboratory testing suture needles, blood vials, needles with attached tubing, and that include values and standards such as scientific credibility, culture dishes (regardless of presence of infectious agents). Also scientific accountability, objectivity, assurance of scientific included are other types of broken or unbroken glassware (e.g., integrity, responsible collaboration, responsible authorship microscope slides and cover slips).
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Software development life cycle (SDLC): a guideline awarded summaries, or statement of deliverables and outcomes for developing systems or software that involves progressive realized through a training activity included in a funding phases spanning the life cycle of the system from initiation reconciliation report. to disposition. Transportation security plan: a written security plan based Staff engagement: the heightened connection between staff on an assessment of possible transportation-related security risks and their work, their organization, or the persons for or with for shipments of hazardous materials that includes appropriate whom they work. Engaged staff find personal meaning in their measures to address these risks. The security plan should address work, take pride in what they do and where they do it, and staff security, unauthorized access, and en-route security. believe that their organization values them. Validation: the action (or process) of proving that a new Standard operating procedures (SOPs): established procedure, process, test system, or method used works procedures to be followed in carrying out a given operation or as expected and achieves the intended results. It includes in a given situation. Development of procedures is based on determination of performance characteristics (i.e., accuracy, prudent laboratory practices that conform to safety guidelines precision, sensitivity, specificity). Examples include validation and regulatory requirements. of a new diagnostic assay or information system. Strain typing methods: methods to distinguish different Verification: the ongoing process that confirms specified strains of infectious agents. Examples include pulse-field gel requirements (predetermined by validation) are fulfilled. electrophoresis (PFGE), multiple-locus variable number tandem Verification is needed when the laboratory replaces a test system repeat analysis (MLVA), and whole-genome sequencing (WGS). or instrument; adds a new test; or changes the manufacturer Strategic thinking: a process by which a person develops a of a test kit. The laboratory must verify the manufacturer’s vision or goal and then works backward to develop a plan to performance specifications are substantiated. An example accomplish that vision or goal. includes the confirmation of results obtained on an automated Systems thinking: the set of habits or processes that testing analyzer of an assay approved by the U.S. Food and permits a person to approach problems by visualizing and Drug Administration. understanding interrelationships rather than linear-cause- Vocabulary standard: vocabularies and systems of encoding effect chains, and by perceiving change as a series of on-going data that have been defined by various standards development processes or events rather than as a single endpoint. organizations. Reliance on these standards for terminology and Training evaluation process: the gathering of information or coding of data greatly improves semantic understanding and, data that takes place at the end of the training implementation therefore, the value of the data in analyses and decision-making. or a specified period of time following training. It measures the Waste management plan: a written set of procedures that effectiveness of the training (e.g., participant learning outcomes). describe decontamination practices and how the different waste Training evaluation tools: methods that include assessment streams (e.g., biologic, chemical, or radiological) generated in of skills and knowledge gaps, impact evaluation, return on the laboratory will be handled to comply with regulatory and investment, and participant reaction evaluation. It is usually an organizational requirements. assessment tool administered to participants after the training Work practices: actions performed by workers, such as activity to determine whether or not course design efforts were decontaminating a work surface, with the goal of preventing or successful from the participants’ perspectives. reducing the risk of exposure to hazardous materials or situations. Training modality: the delivery method used to provide Workflow: 1) sequential steps in a laboratory’s activities training and education (e.g., in-person seminars, eLearning, web- that transform a submitter’s test order into the laboratory based interaction, conferences, workshops, or teleconferences). information captured in the report of results, including pre- Training report: a document produced during the examination, examination, and postexamination procedures; development of, and following, the delivery of a training 2) all of the tasks, in the proper order, required to carry out activity. Reports might include training program evaluation a process. summaries, attendance and continuing education credits
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Project Governance Members Project Manager: Catherine Johnson, MA, Association of Public Health Laboratories, Silver Spring, Maryland. Facilitators: Mike Smith, PhD, Lead Facilitator, LuAnne Forrest, PhD, Kerrie Naylor, PhD, Janice Schonwetter, MS, Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah. Project Consultant: Kathleen Miner, PhD; Emory University, Rollins School of Public Health, Atlanta, Georgia. Steering Committee: John M. DeBoy, DrPH,* Catherine Johnson, MA, Eva Perlman, MPH, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Judy R. Delany, MS, MPH,* Renée M. Ned-Sykes, PhD, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Wendi Kuhnert, PhD, National Center for Emerging and Zoonotic Infectious Diseases, Janet Nicholson, PhD,* Office of Infectious Diseases, Penney Reese, MS, Office of Public Health Preparedness and Response, CDC, Atlanta, Georgia.
Project Planning Workgroup Members John M. DeBoy, DrPH,* Catherine Johnson, MA, Eva Perlman, MPH, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; LuAnne Forrest, PhD, Mike Smith, PhD, AlignOrg Solutions, Salt Lake City, Utah; Laura Gillim-Ross, PhD, Colorado Department of Public Health and Environment, Laboratory Services Division, Denver, Colorado; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories– Miami, Miami, Florida; Sara B. Imholte, MPH, Kathryn Wangsness, MHA, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Kathleen Miner, PhD, Emory University, Rollins School of Public Health, Atlanta, Georgia; Rick Panning, MBA, Fairview Health Services, Minneapolis, Minnesota; James Pearson, DrPH, Association of Public Health Laboratories, Silver Spring, Maryland; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts; Scott M. Shone, PhD, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Brenda Snodgrass, Oklahoma Department of Agriculture, Food and Forestry, Oklahoma City, Oklahoma; Michael Wichman, PhD, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Eddie Ades, PhD,* Melissa Olsen-Rasmussen, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Ann Berry, PhD, National Institute for Occupational Safety and Health, Judy R. Delany, MS, MPH,* Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Ritchard Parry, MS, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Susan Hunter, MS,* Wendi Kuhnert, PhD, Scott A. Sammons, MS, Angela Slaughter, National Center for Emerging and Zoonotic Infectious Diseases, Robert Kobelski, PhD, Tonia Parrott, PhD, National Center for Environmental Health, Janet Nicholson, PhD,* Office of Infectious Diseases, Penney Reese, MS, Office of Public Health Preparedness and Response, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia; Robert Lanciotti, PhD, National Institute for Occupational Safety and Health, CDC, Morgantown, West Virginia.
Competency Domain Team Members Quality Management System Team leads: Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Debra Kuehl, MS, Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Members: Jack Bennett, Connecticut Environmental Chemistry Laboratory, Rocky Hill, Connecticut; Jill Power, MS, New Hampshire Department of Health and Human Services, Public Health Laboratories, Concord, New Hampshire; Karen Stephani, New York State Department of Agriculture and Markets, Albany, New York; Tamara Theisen, Saginaw County Department of Public Health, Saginaw, Michigan; Xin Liu, PhD, Center for Global Health, CDC, Atlanta, Georgia. Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Ethics Team lead: Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Members: Catherine Johnson, MA, Association of Public Health Laboratories, Silver Spring, Maryland; Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Management and Leadership Team leads: John M. DeBoy, DrPH, Association of Public Health Laboratories, Silver Spring, Maryland;* Rick Panning, MBA, Fairview Health Services, Minneapolis, Minnesota. Members: Robyn Atkinson, PhD, Utah Public Health Laboratory, Taylorsville, Utah; Elizabeth Franko, DrPH, Georgia Public Health Laboratory, Decatur, Georgia; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Steve Gradus, PhD, City of Milwaukee Public Health Laboratory, Milwaukee, Wisconsin; Richard Harris, Wyoming Public Health Laboratory, Cheyenne, Wyoming; John Krueger, MS, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia. Facilitator: Kerrie Naylor, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Communication Team leads: Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Kathryn Wangsness, MHA, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Susan Hunter, MS, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.* Members: Erin Bowles, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Tim Church, Washington Department of Health, Tumwater, Washington; Rick France, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida; Leslie McDonald, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Facilitator: LuAnne Forrest, PhD, AlignOrg Solutions, Salt Lake City, Utah.
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Security Team leads: Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Kathleen Keyes, MS, National Center for Emerging and Zoonotic Infectious Diseases, Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Members: Jennifer Gaudioso, PhD, Sandia National Laboratories, Albuquerque, New Mexico; M. Kristy Osterhout, North Carolina State Laboratory of Public Health, Raleigh, North Carolina; Robert Rice, US Department of Agriculture, Animal and Plant Health Inspection Service, Washington, District of Columbia; Miki Van Houten, Oregon State Public Health Laboratory, Portland, Oregon; Paul Meechan, PhD, Office of Safety, Security and Asset Management, CDC, Atlanta, Georgia. Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Emergency Management and Response Team lead: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida. Members: Christopher Chadwick, MS, Chris Mangal, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Christina Egan, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Bonnie Rubin, MLS, MBA, MHA, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Maureen Sullivan, MPH, Minnesota Department of Health, Public Health Laboratory, St. Paul, Minnesota; Victor Waddell, PhD, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Susan Hiers, MPH, National Center for Emerging and Zoonotic Infectious Diseases, Tonia Parrott, PhD, Rudolph Johnson, PhD, National Center for Environmental Health, CDC, Atlanta, Georgia.
Workforce Training Team lead: La’Vonda Benbow, North Carolina State Laboratory of Public Health, Raleigh, North Carolina. Members: Mary E. Hochstedler, Bonnie Rubin, MLS, MBA, MHA, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Valerie Johnson, MSPH, Ritchard Parry, MS, Center for Surveillance, Epidemiology, and Laboratory Services, Robert Kobelski, PhD, National Center for Environmental Health, CDC, Atlanta, Georgia. Facilitator: LuAnne Forrest, PhD, AlignOrg Solutions, Salt Lake City, Utah.
General Laboratory Practice Team lead: Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Members: Erin Bowles, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Patrick Dhooge, PhD, New Mexico Department of Health, Scientific Laboratory Division, Albuquerque, New Mexico; Douglas Haltmeier, MS, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Catherine Johnson, MA, Association of Public Health Laboratories, Silver Spring, Maryland; Martha Smith, MPA, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Debra Kuehl, MS, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.
Safety Team leads: Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Kathleen Keyes, MS, National Center for Emerging and Zoonotic Infectious Diseases, Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Members: Jennifer Gaudioso, PhD, Sandia National Laboratories, Albuquerque, New Mexico; M. Kristy Osterhout, North Carolina State Laboratory of Public Health, Raleigh, North Carolina; Robert Rice, US Department of Agriculture, Animal and Plant Health Inspection Service, Washington, District of Columbia; Miki Van Houten, Oregon State Public Health Laboratory, Portland, Oregon; Paul Meechan, PhD, Office of Safety, Security and Asset Management, CDC, Atlanta, Georgia. Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Surveillance Team leads: Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Kathryn Wangsness, MHA, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Susan Hunter, MS, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.* Members: Diane Eckles, Arizona Department of Health Services, Office of Environmental Health, Phoenix, Arizona; Kirsten Larson, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Steve Marshall, MS, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Karen Anderson, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia. Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Informatics Team leads: Cassandra Hadley, John Krueger, MS, Association of Public Health Laboratories, Silver Spring, Maryland. Members: Willie Andrews, Virginia Department of General Services, Division of Consolidated Laboratory Services, Richmond, Virginia; Kakali Bandyopadhyay, PhD, Booz Allen Hamilton, Atlanta, Georgia; Mark Conde, Emory University, Rollins School of Public Health, Atlanta, Georgia; Paul Duffey, PhD, California Department of Public Health Laboratory, Moraga, California;* Reshma Kahhar, The St. John Group, Atlanta, Georgia; Garrett Peterson, MBA, Yahara Software, Madison, Wisconsin; Robert Sokolow, Association of Public Health Laboratories, Silver Spring, Maryland; Mary Kathryn Yost-Daljev, PhD, Virginia Department of General Services, Division of Consolidated Laboratory Services, Richmond, Virginia; Patricia Fields, PhD, National Center for Emerging and Zoonotic Infectious Diseases, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Facilitator: Janice Schonwetter, MS, AlignOrg Solutions, Salt Lake City, Utah.
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Microbiology Team leads: Kimberlee Musser, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts. Members: Erin Bowles, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; John Barnes, PhD, Rebecca McNall, PhD, National Center for Immunization and Respiratory Diseases, Brandi Limbago, PhD, National Center for Emerging and Zoonotic Infectious Diseases, Melissa Olsen-Rasmussen, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia. Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Chemistry Team lead: Scott M. Shone, PhD, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey. Members: Martin Bevan, Betsy Edhlund, PhD, Minnesota Department of Health, Public Health Laboratory, St. Paul, Minnesota; Patrick Dhooge, PhD, New Mexico Department of Health, Scientific Laboratory Division, Albuquerque, New Mexico; Douglas Haltmeier, MS, Martha Smith, MPA, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Jason Mihalic, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Michael Wichman, PhD, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Tonia Parrott, PhD, National Center for Environmental Health, CDC, Atlanta, Georgia; Robert Lanciotti, PhD, National Institute for Occupational Safety and Health, CDC, Morgantown, West Virginia. Facilitator: Janice Schonwetter, MS, AlignOrg Solutions, Salt Lake City, Utah.
Bioinformatics Team lead: Scott A. Sammons, MS, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia. Members: Ed Simpson, Indiana State Department of Health, Public Health Laboratory, Indianapolis, Indiana; William Wolfgang, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Duncan MacCannell, PhD, National Center for Emerging and Zoonotic Infectious Diseases, Elizabeth Neuhaus, PhD, National Center for Immunization and Respiratory Diseases, James Posey, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, Georgia. Facilitator: Janice Schonwetter, MS, AlignOrg Solutions, Salt Lake City, Utah.
Research Team leads: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories – Tampa, Tampa, Florida; Laura Gillim-Ross, PhD, Colorado Department of Public Health and Environment, Laboratory Services Division, Denver, Colorado. Members: Joanne Bartkus, PhD, Minnesota Department of Health, Public Health Laboratory, St. Paul, Minnesota; Peter Iwen, PhD, Nebraska Public Health Laboratory, University of Nebraska Medical Center, Omaha, Nebraska; Denise Kay, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Matthew Arduino, DrPH, National Center for Emerging and Zoonotic Infectious Diseases, Ruben Donis, PhD, National Center for Immunization and Respiratory Diseases, Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Facilitator: Kerrie Naylor, PhD, AlignOrg Solutions, Salt Lake City, Utah.
Workgroup Members Development: John M. DeBoy, DrPH,* Catherine Johnson, MA, Eva Perlman, MPH, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; LuAnne Forrest, PhD, Kerrie Naylor, PhD, AlignOrg Solutions, Salt Lake City, Utah; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts; Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Synthesis: John M. DeBoy, DrPH,* Catherine Johnson, MA, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Mike Smith, PhD, Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah; Judy R. Delany, MS, MPH,* Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia. Adjudication Process: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida; John M. DeBoy, DrPH,* Catherine Johnson, MA, John Krueger, MS, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Kathleen Keyes, MS, Scott A. Sammons, MS, Leigh Vaughan, National Center for Emerging and Zoonotic Infectious Diseases, Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia. Harmonization of Domains: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida; John M. DeBoy, DrPH,* Catherine Johnson, MA, John Krueger, MS, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Leigh Vaughan, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.
* Indicates a person who has retired.
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ISSN: 1546-0738