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4/27/2020 Competency Guidelines for Public Health Laboratory Professionals: CDC and the Association of Public Health Laboratories

Morbidity and Mortality Weekly Report (MMWR)

Competency Guidelines for Public Health Laboratory Professionals: CDC


and the Association of Public Health Laboratories
Supplements
May 15, 2015 / 64(01);1-81

Prepared by
Renée Ned-Sykes, PhD1
Catherine Johnson, MA2
John C. Ridderhof, DrPH1
Eva Perlman, MPH2
Anne Pollock3
John M. DeBoy, DrPH2
1Office of Public Health Scientific Services, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta,
Georgia
2Association of Public Health Laboratories, Silver Spring, Maryland
3Office of Public Health Scientific Services, Center for Surveillance, Epidemiology, and Laboratory Services, Division of
Laboratory Systems, CDC, Atlanta, Georgia
Corresponding preparer: Renée Ned-Sykes, RNed@cdc.gov, 404-498-0125.

Summary
These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory (PHL)
professionals to deliver the core services of PHLs efficiently and effectively. As part of a 2-year workforce project sponsored
in 2012 by CDC and the Association of Public Health Laboratories (APHL), competencies for 15 domain areas were
developed by experts representing state and local PHLs, clinical laboratories, academic institutions, laboratory
professional organizations, CDC, and APHL. The competencies were developed and reviewed by approximately 170 subject
matter experts with diverse backgrounds and experiences in laboratory science and public health. The guidelines comprise
general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent,
proficient, and expert. The 15 domain areas are 1) Quality Management System, 2) Ethics, 3) Management and Leadership,
4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory
Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research.
These competency guidelines are targeted to scientists working in PHLs, defined as governmental public health,
environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related
services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental
hazards, treatable hereditary disorders, and natural and human-made public health emergencies. The competencies
support certain PHL workforce needs such as identifying job responsibilities, assessing individual performance, and
providing a guiding framework for producing education and training programs. Although these competencies were
developed specifically for the PHL community, this does not preclude their broader application to other professionals in a
variety of different work settings.

Introduction
The national network of governmental public health, environmental, and agricultural laboratories, referred to collectively as
public health laboratories (PHLs), is a vital part of the U.S. public health infrastructure. These laboratories perform multiple
functions through provision of analytic biological and/or chemical testing and testing-related services that protect human
populations from infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary
disorders, and other natural and human-made public health emergencies (1–3). A well-trained laboratory workforce is
essential to ensuring that PHLs have the capacity to carry out the critical activities that are needed to safeguard the public's
health competently and effectively (4,5).
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Studies of the PHL workforce have drawn attention to several concerns about staff training and projected turnover, both of
which highlight challenges to maintaining a sufficient number of highly skilled and competent workers. A 2011 national PHL
workforce characterization survey found that approximately one third of PHL directors nationally expected 16%–25% of their
workforce to retire, resign, or be released in the subsequent 5 years, while 12% anticipated losing 26%–50% of their workforce
during that time period (6,7). Approximately 30% of the individual scientific staff respondents expected to continue working
in a PHL for <5 years (6). These findings largely reflect workforce demographics, because more than half of scientific
laboratory staff were aged >45 years (6). Important recruitment and retention challenges for the PHL workforce also have
been identified, including the lack of established progressive job series (commonly termed "career ladders" in the PHL
community) for PHL scientists (6–8) and the lack of adequate opportunities for training and professional development (6,7).
Indeed, approximately 50% of laboratories reported no, minimal, or only partial capacity to provide continuing education and
training to their workers (6,7). Lack of adequate training poses challenges because PHL scientists and managers require a
range of scientific, leadership, and managerial development courses, ideally based on core competencies, to function
effectively in their positions (9–11).
Multiple national professional organizations, including the Institute of Medicine, the Association of Schools and Programs of
Public Health, and the Public Health Foundation/Council on Linkages Between Academia and Public Health Practice
(Council on Linkages), among others, have endorsed competency development as a means of strengthening the public health
workforce (12–15). Competencies improve the workforce by providing a guiding framework for producing education and
training programs, identifying worker roles and job responsibilities, and assessing individual performance and organizational
capacity (12–18).
Competencies are action-oriented statements that delineate the essential knowledge, skills, and abilities that are critical to the
effective and efficient performance of work (19); competencies should be observable and measurable. Several public health
professional disciplines have developed competencies, often through federal partnerships, to address workforce education
and training needs (14,15,19–24), and competency-based curriculum development has been suggested as the ideal method for
training public health workers and public health students (10,11,13,18,25). In 2009, CDC and APHL collaborated to develop
guidelines for biosafety laboratory competency (26), followed by development of this broader set of guidelines for PHL
professional competency.

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

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

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

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Eleven Domain Teams then were established to develop competencies for 14 draft competency domains; an additional
domain focused on ethics was developed later in the process. Most team leads and many members were drawn from the
Project Planning Workgroup. Each team lead was responsible for making recommendations regarding team membership to
the CDC/APHL Steering Committee and APHL staff, who vetted potential members. Domain Team leads were encouraged to
recruit a diverse group based on employer type (government and nongovernment, and federal, state, and local), geographic
locale of employment, and years and range of experience (laboratory scientists, managers, and leaders). A total of 90 subject
matter experts from CDC, state and local PHLs, APHL, academic laboratories, clinical laboratories, the U.S. Department of
Agriculture, and others served on the various Domain Teams.
A Development Workgroup created template documents to assist the Domain Teams in constructing their respective
competency sets and to ensure uniformity to the process. This Workgroup, which comprised staff from CDC, APHL, PHL, and
AlignOrg Solutions, conducted literature reviews and Internet searches to identify related materials, including laboratory
association guidelines and reports as well as competency sets for nonlaboratory audiences that had application for PHL
functions or specific domain areas (e.g., management, leadership, and workforce training). Although applicable literature was
located for eight domain areas (Quality Management System, Management and Leadership, Ethics, Safety, Research,
Emergency Management and Response, Workforce Training, and Informatics), limited material was found related to the
remaining competency domains. Formal systematic review methods were not used because of the scarcity of available
literature, especially regarding laboratory-specific content. In December 2012, the Development Workgroup met to draft a
template document for each competency domain, consisting of main competency statements comprising one or more
subcompetencies that were further defined by draft responsibility statements at one or more proficiency levels. The
Workgroup members used the available literature when applicable but relied principally on their subject matter knowledge
and personal work experience as a basis for drafting the template documents.
During January 2013–April 2013, each Domain Team held regular, facilitated conference calls to develop and refine their
respective domain competencies, using the template document provided by the Development Workgroup as a starting point.
Each team relied on member expertise to arrive at consensus on all competencies, subcompetencies, and proficiency tier
statements. The 14 proposed PHL competency domains were mapped against the core functions of PHLs (2,3), the Council on
Linkages Core Competencies for Public Health Professionals (14), and the CDC/Council of State and Territorial
Epidemiologists Applied Epidemiology Competencies (15) to assess congruence with these materials and to identify gaps in
the draft PHL competency domains.
In April 2013, a six-person Synthesis Workgroup was established to review and assess the draft domain documents for gaps
and overlaps in content and to harmonize language across domains. During May–November 2013, the Workgroup's efforts
focused on developing definitions for each domain, continuing to harmonize content and address gaps and overlaps,
developing an online survey tool for the competency validation process, and soliciting reviewers to evaluate one or more
competency domains.

Validation Process
The CDC/APHL Steering Committee identified the organizations and agencies it wanted to target for involvement in the
competency validation process. Following a solicitation for reviewers, APHL staff contacted 139 potential reviewers on the
basis of their knowledge and background in one or more particular domain areas. Of these, 75 were invited and agreed to
participate in the review phase. Reviewers were drawn from state and local PHLs, CDC, APHL, clinical laboratory
organizations, and food-testing laboratories, as well as former PHL directors and other expert consultants. Fifteen reviewers
already had been involved in the competency development process in some capacity and offered to review domains that they
did not take part in developing. Reviewers were given 45 days during November 2013–January 2014 to assess the validity of
the content for the particular domain(s) reviewed and to provide comments and recommendations for improvement through
an online survey tool. The reviewers based their responses on their knowledge and experiences in laboratory practice. In
December 2013, an Adjudication Process Workgroup of APHL, CDC, and PHL representatives met to design and establish the
process for adjudicating reviewer comments, including a method for each Domain Team to document its response to each
comment received. At the end of the vetting period, all reviewer comments were collated and reviewed by APHL staff, and a
consolidated listing of comments was forwarded for review to the Domain Teams.
The extensive nature of the comments for the General Laboratory Practice and Emergency Management and Response
domains prompted the CDC/APHL Steering Committee to create dedicated teams for each of these domains. Several
competencies and subcompetencies for the General Laboratory Practice domain had been extracted previously from the
Chemistry and Microbiology domains, with additional content developed by a small work team. The new General Laboratory
Practice Domain Team included representatives from the Chemistry, Microbiology, Quality Management System, Research,
and Communication Domain Teams. Content for the Emergency Management and Response domain had also been
developed initially by the Chemistry and Microbiology Domain Teams. In light of the vetting period comments, the
Emergency Management and Response domain competencies were rewritten by a dedicated team that included members
from APHL's Public Health Preparedness and Response department and the APHL Public Health Preparedness and Response
Committee. Similarly, content for the Ethics domain had been extracted from a number of existing domains, and three

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Domain Team volunteers formed a new team to examine comments received. All Domain Teams held as many conference
calls as needed during January–March 2014 to consider and address the vetting period comments.
In April 2014, a Harmonization of Domains Workgroup met to review major changes that the Domain Teams had made to the
draft competencies in response to reviewer comments and to address any remaining overlaps in content and inconsistencies
in approach and language among the competency domains. The Workgroup also resolved outstanding issues related to
vetting period comments that the Domain Teams were unable to address individually in a consensus process. This workgroup
comprised nine Domain Team leads, two CDC/APHL Steering Committee members, the APHL project manager, and an
invited representative of CDC. Workgroup members then split into small teams and met via teleconference during April–July
2014 to finalize the competency domains.
In total, the competencies were developed and reviewed by approximately 170 professionals with diverse backgrounds and
experiences in laboratory science and public health. The final draft of the competency guidelines was reviewed by the
CDC/APHL Steering Committee in October 2014. The final competency guidelines were reviewed and approved by CDC in
February 2015.

Guiding Principles
Scope
The competency guidelines were developed specifically for scientists working in PHLs. APHL defines PHLs as governmental
public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and
testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases,
environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies
(http://www.aphl.org/aboutaphl/aboutphls/pages/default.aspx ). Although intended primarily for the continuum of
scientist positions from laboratory assistant to laboratory director, these competencies can be used by other PHL staff as well.
In fact, all staff (including administrative and support staff, custodial staff, and information technology specialists) can apply
competencies within the Security, Safety, Emergency Management and Response, and Ethics domains. Any staff members
with responsibilities for data entry, records management, client services, supply services, and other nonbench functions
would benefit from application of competencies across additional domains depending on their job function and
responsibilities.
Although these competencies were developed expressly for the PHL community, this does not preclude their broader
application to a variety of other work settings, because many of the skill sets are similar. Scientists, trainers/educators, and
leaders and managers in clinical laboratories, veterinary laboratories, academic and private research laboratories, and other
laboratories may use these competencies as a basis for further development of their workforce and local/institutional staff.
Laboratories using these competencies should be mindful of federal, state, local, and institutional regulations and standards
addressing topics such as safety and security when adopting competencies in practice.

Competencies and Skill Domains


These guidelines were developed on the basis of the Dreyfus Model of Skill Acquisition, which states that five progressive
stages of development are associated with skill proficiency (18,28). Learners are able to handle additional responsibility and
adjust to different and more complex situations as they gain proficiency. For these competency guidelines, the Dreyfus Model
was modified in that four proficiency tiers are used: beginner, competent, proficient, and expert. Descriptions of the
proficiency tiers are provided (Appendix A).
Competencies were written by using Bloom's taxonomy as a framework; action verbs describing activities that are observable
and measurable were used to signify or relate to a hierarchy of learning and actions (29,30). The hierarchy of responsibilities
is based on the science for competency development that has been applied across numerous disciplines. Competencies
typically are structured as broad statements that define what is expected of and can be demonstrated by the learner;
therefore, specific tasks or methods to achieve the competency at a particular proficiency level are not delineated. Each user is
responsible for deciding the needed activities, which might vary substantially because of the diversity that exists within and
across public health laboratories. Consequently, competency statements do not refer to or include the frequency with which a
responsibility is exercised. Nor, with rare exceptions, do they refer to specific guidelines, standards, or regulations, because
these might differ by discipline and type of laboratory. The competencies focus on the knowledge, skills, and abilities required
to perform a range of activities in the PHL. The competencies convey the capability for a given behavior or skill, even if the
opportunity to perform that skill or behavior is not available (e.g., to serve on national committees or instruct others in
policies and processes).
A total of 122 competencies and 519 subcompetencies were identified for the PHL workforce across 15 competency domains:
1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency
Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11)
Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research (Figure). Full descriptions of these
domains and listing of their competencies, subcompetencies, and responsibility statements are presented (Tables 1–15). A
number and lettering schema is used to identify domains, competencies, and subcompetencies. Domains are identified by
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three-letter initials (e.g., QMS), competencies are identified by the domain initials and an overall number (e.g., QMS 1.00),
and subcompetencies are further identified through expansion on the competency numbering system (e.g., QMS 1.01 and
QMS 1.02).
Three types of domains are included in this competency set: 1) general domains that apply to the responsibilities of all PHL
professionals (i.e., Quality Management System, Ethics, Management and Leadership, Communication, Security, Emergency
Management and Response, and Workforce Training); 2) cross-cutting technical domains that apply to all laboratory
scientists regardless of the scientific discipline in which they work (i.e., General Laboratory Practice, Safety, Surveillance, and
Informatics); and 3) specialized domains that are specific to laboratory scientists working in particular scientific disciplines or
specialized functional areas (i.e., Chemistry, Microbiology, Bioinformatics, and Research) (Figure). The General Laboratory
Practice domain is broadly applicable because it includes general topics pertinent to the laboratory workflow across a wide
array of testing areas. Many of these subcompetencies are not duplicated in the specialized domains. Consequently, the
General Laboratory Practice domain serves two purposes: to be a companion to each specialized domain and to function as a
quasispecialized domain for testing activities not encompassed by the Microbiology or Chemistry domains. Because many
topics are relevant to more than one competency domain, the Harmonization of Domains Workgroup decided when to have
intentional overlap of particular subcompetencies or topics across domains. For example, the General Laboratory Practice,
Research, and Management and Leadership domains include ethics-related competencies although there is a separate Ethics
domain.
For all domains, the competencies and proficiency tier statements are context-driven. A given verb is not limited to occurring
at only one specific level of proficiency, as the complexity of the described action is determined by the context. In addition,
some subcompetencies are similar across domains, in which case users should be mindful of the specific context. For
example, sample collection, labeling, and handling are primary functions for both chemistry and microbiology. The
subcompetency language for this group of activities is similar in the Chemistry and Microbiology domains, although the
specific actions (tasks) needed to achieve each level of proficiency might be different between the testing disciplines.
Each subcompetency outlines a cumulative acquisition of skills, with each successive proficiency tier assuming that a person
has acquired the knowledge, skills, or abilities stated in the lower proficiency tier for a given subcompetency. However, the
amount of time required for a worker to achieve competency at a particular proficiency tier might be highly variable. In
particular, the beginner phase could encompass a very short time frame for some subcompetencies while requiring a longer
time for others, depending on the specific action described. Regardless, all beginner tier statements assume that work will be
performed under supervision. Furthermore, all statements of the four proficiency tiers are written under the assumption that
work will be performed according to standard operating procedures, processes, and policies approved by the administration
of the laboratory and in adherence to applicable regulations and accreditation standards and guidelines.
Finally, no recommendation is made that any particular job title or academic degree is required for a particular proficiency
tier, nor is the complexity of the knowledge, skills, and abilities for a given proficiency tier the same for all competencies. For
example, a PHL scientist could be at the beginner tier for some subcompetencies while being at the competent or proficient
tier for others. Similarly, a person might acquire some expert tier competencies early in their career despite not having
supervisory or management responsibilities. Many expert competency statements, however, apply to a person occupying a
position commensurate with a laboratory director, as significant experience and expertise are required.

Intended Use
These guidelines provide highly structured competencies intended to help ensure a capable, well-trained, and prepared
laboratory workforce. The competence of the PHL workforce has a direct impact on the quality of the work output and
products required to protect the public's health. Each competency and subcompetency within every domain might not apply
to all laboratory staff. The competencies should be tailored and applied to the greatest extent possible to the individual user's
situation. Personnel can use the competencies to assess their current skill level and define other areas in need of additional
training, with a goal of achieving higher proficiency over time. Laboratory directors and human resources staff might find the
guidelines helpful in creating standardized job descriptions, defining progressive job series, recruiting new staff, assessing
organizational capacity, and developing performance objectives and appraisals that are aligned with the competencies.
Laboratory managers may employ the guidelines as a reference for performance management strategies. The competencies
provide a framework for assessing performance and could be used to prepare for certification examinations and for meeting
staff qualification requirements specified by governmental laboratory personnel regulations. Finally, educators and training
developers may use the guidelines to develop and refine PHL workforce development plans to assess and address training
needs through the design of education and training programs.
It is important for users to review the definitions associated with these guidelines (Appendix B). As terms might have
different meanings in the context of different laboratory types, the terminology for this project has been standardized to
provide more clarity and ease in applying the competencies to practice settings. In situations in which glossary terms contain
more than one possible definition, the particular definition applicable to a domain is footnoted for that domain.

Dissemination
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CDC and APHL plan to disseminate these guidelines broadly to a variety of stakeholders, including, but not limited to public
health laboratories, clinical laboratories, academia, and laboratory scientist professional organizations such as the American
Society for Clinical Pathology, the American Society for Clinical Laboratory Science, the Association of Food and Drug
Officials, the Association of American Feed Control Officials, the Clinical Laboratory Management Association, and the
Clinical and Laboratory Standards Institute, some of which participated in the competency validation process. The
competencies will be presented at meetings of public health practitioners and laboratory professionals. The guidelines also
will be displayed on APHL's website (http://www.aphl.org ).
The next stage of this PHL competency project will focus on the development of tools and resources to aid in guideline
implementation. These might include sample competency-based job descriptions and examples of ways professionals can
demonstrate competency in a specific area; highlight case study examples of competencies in use; and provide models for
developing training and fellowship programs tied to performance metrics and competencies. For example, the Emerging
Infectious Diseases Fellowship Program, which is sponsored by APHL and CDC, could use guidance in the toolkit to integrate
these competencies into a training program similar to the manner in which the CDC-sponsored Epidemic Intelligence Service
program (31) integrated the Applied Epidemiology Competencies (15). Tools and resources to support implementation will
also be displayed on APHL's website (http://www.aphl.org ) as they are developed.
CDC and APHL also aim to develop a sustainability plan to evaluate the adoption, use, and need for revision of these
guidelines periodically. The Council on Linkages (14) and the Clinical and Laboratory Standards Institute (32) provide models
for competency and guideline revision that could support this process.

Quality Management System Competency Guidelines


Purpose statement: The competencies in Quality Management System (QMS) address the knowledge, skills, and abilities
required for developing a laboratory's culture of quality (Table 1). The essential elements integrate operations, services, and
infrastructure into a system that meets applicable regulatory standards, professional guidelines, and customer requirements
for ensuring and maintaining quality and continually improving laboratory services.
Introduction: QMS is a systematic approach for ensuring the consistent quality of the tests performed, the products
created, the data generated, and the results reported. Operating within a quality system meets the needs and requirements of
public health laboratories as well as the expectations of partners, stakeholders, and users (internal and external customers). A
QMS is more than quality assurance and quality control — it also includes all the business processes of a laboratory that are
required to ensure quality. Adhering to quality standards for laboratory operations helps laboratories generate consistent,
reliable, and reproducible data and results.
As the first responsibility of the public health laboratory staff is to provide quality testing and services to support the health of
the public and meet the many needs of their customers, this demand for quality is superimposed on all aspects of laboratory
operations. As such, a quality management system is the foundation for every other activity within this competency set.
Notes: The structure for this domain is based upon the 12 quality system essentials (33). Multiple additional sources were
identified as support documents for this domain (34–40). As the foundational domain for these guidelines, all other
competencies should be viewed within its context. However, this domain is systems-oriented. Other domains contain quality-
related subcompetencies that address "bench-level" quality indicators and activities and not the creation, maintenance, and
evaluation of a quality management system as presented here. The verb "oversees" is used extensively in the Expert level. In
this context, "oversees" is a broad term that comprises the many functions related to the management of policies, processes,
and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration.

Ethics Competency Guidelines


Purpose statement: The competencies in Ethics address the knowledge, skills, and abilities needed to fulfill basic
responsibilities to perform in a collegial and ethical manner within a laboratory setting (Table 2). Ethical professional and
scientific behaviors are essential when working in the public health laboratory to help ensure scientific integrity and sustain
effective relationships with stakeholders and the public.
Introduction: Ethics are principles or a set of values held by a person or group, i.e., the rules or standards governing the
conduct of a person or the conduct of the members of a profession. These principles and rules include characteristics such as
personal accountability, maintaining confidentiality, and ensuring the accuracy of testing results. These vital but sometimes
unspoken values, standards, and resulting professional and scientific codes of conduct are critical to establishing and
maintaining a collegial environment in which scientific integrity is held in the highest regard.
To carry out its mission, the public health laboratory must earn and maintain the public's trust. As diligent stewards of that
trust and of public funds, all public health laboratory staff should act decisively and ethically in service to the public's health.
Laboratory staff should apply ethical principles in all aspects of their work, including respecting their colleagues, customers,
and populations they serve. Individual laboratory staff members should apply ethical principles in decision-making to all
aspects of their job performance and take responsibility for outcomes associated with their decisions. Ethics must exist at
every level in the organization; and it must be championed by every staff person, not just leadership.
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Notes: Multiple sources were identified as support documents for this domain (41–45). This domain is intentionally broad
and includes examples of general and scientific ethics and practices in the glossary. It is the responsibility of each
organization to further identify and detail the professional and scientific values and characteristics important to them. The
General Laboratory Practice, Research, and Management and Leadership domains also include ethics-related competencies.

Management and Leadership Competency Guidelines


Purpose statement: The competencies in Management and Leadership address the knowledge, skills, and abilities related
to managing staff (supervision), the science and practice of achieving results using available resources (management), and the
process of influencing the actions of a person or group to attain desired objectives (leadership) (Table 3).
Introduction: Management and leadership are distinct and complementary roles, both of which are necessary for the
success of an organization. They can be distinguished in a number of ways (46). Leadership establishes the purpose and
strategic direction of the organization. Leading involves innovating, influencing, and motivating. Leadership asks "what" and
"why" and mainly works with persons and their interrelationships. Management establishes the systems and processes of the
organization. Managing involves administering, planning, organizing, and coordinating. Management asks "how" and "when"
and mainly works with systems, processes, mechanisms, models, and structures. Leadership challenges and improves
accepted policies and processes and ensures alignment with the mission and vision of the laboratory (i.e., strives to do the
right things). Management works within accepted administrative policies and processes to accomplish the mission and vision
of the laboratory (i.e., strives to do things right). Effective management and leadership are both critical to accomplishing the
core functions of public health laboratories (2,3).
All staff members require a certain degree of management and leadership skills. The scope of work performed by public
health laboratories is complex and, therefore, requires staff members who have the crucial leadership and management
knowledge and skills to be effective in such an environment. Public health laboratories have a great need to develop these skill
sets, as there is a severe and continuing shortage of scientists qualified to assume management and leadership positions. This
situation is made more challenging because staff members are rarely provided formal training in these areas through degree,
fellowship, or other programs.
Notes: Multiple sources were identified as support documents for this domain (4,10,11,14,15,35,37,46,47), which supports all
other domains in these guidelines. This domain is intended for all staff, not just those with managerial or leadership positions
or job titles. It is sometimes difficult to separate a skill, behavior, or process as belonging exclusively to either management or
leadership. As such, leadership subcompetencies are interwoven throughout the domain and are not limited to those within
the Leadership competency (MLD 5.00). Ethics-related competencies are included in this domain that correlate with
competencies found in the Ethics domain.

Communication Competency Guidelines


Purpose statement: The competencies in Communication address the knowledge, skills, and abilities necessary to
disseminate information in a clear and concise manner appropriate to a given audience (Table 4). Communication might
occur in writing, orally, or nonverbally, and it might take place in person or through electronic means.
Introduction: Communication is the application of written, verbal, and nonverbal methods and resources, either in person
or through available technologies, to convey information. Although transmission of information is critical, assurance the
information is accurate, clear, tailored to the audience, and prepared with linguistic aptitude and cultural sensitivity is equally
important.
Effective internal and external communication is necessary for the optimal operation of the public health laboratory. Internal
communication between staff is essential to satisfy the organization's goals and quality management system. External
communication is necessary to disseminate public health information and to highlight the importance of laboratory
contributions in support of public health. Public health laboratories are often called upon to convey the mission, operational
features, and test services (the "why," "how," and "what") of their laboratory. These tasks involve engaging traditional and
nontraditional partners and are critical to ensuring continued interest and support of the public health laboratory system.
Notes: Multiple sources were identified as support documents for this domain (14,15,48,49). Communication skills are
pervasive throughout other domains, including skills such as writing and instructing. Communicating or reporting test orders
and results are not covered here but in the General Laboratory Practice, Chemistry, and Microbiology domains.

Security Competency Guidelines


Purpose statement: The competencies in Security address the knowledge, skills, and abilities necessary to ensure a secure,
protected working environment that meets or exceeds applicable regulatory requirements and guidelines (Table 5).
Introduction: Security is a compilation of elements that include physical, operational, information, and staff protection
with the intent to safeguard personnel and to protect assets and data from unauthorized access, misuse, loss and/or theft.
This is accomplished through the implementation of a comprehensive security management system, founded on accepted

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practices, that ensures that operations are carried out in an environment that is secure and protected at all times. Each person
must consistently carry out their responsibilities to ensure the effective application of security practices.
To meet its mission, the public health laboratory must ensure the security of the environment, infrastructure, staff, and of the
samples and sensitive information with which it is entrusted. Thus, the knowledge, skills, and abilities included in this
domain must be integrated into all technical and nontechnical aspects of staff members' job performances.
Note: Multiple sources were identified as support documents for this domain (50–52).

Emergency Management and Response Competency Guidelines


Purpose statement: The competencies in Emergency Management and Response address the knowledge, skills, and
abilities needed to mitigate, prepare for, respond to, and recover from laboratory-specific emergency events and situations
(Table 6).
Introduction: Emergency Management and Response is a four-phase process involving mitigation, preparedness, response,
and recovery for emergency events and situations that have a direct impact on laboratory operations and surge testing. This
domain recognizes the public health laboratory's mandate to provide emergency response support to external partners.
Emergency management and response encompasses events such as natural disasters or public health emergencies, facility or
operation failures, in addition to the public health responsibility to detect and respond to real or potential biological,
chemical, or radiological threats.
Public health laboratory staff members are responsible for the recognition, response, and management of emergency events
and situations directly impacting laboratory operations and surge testing. Staff members provide outreach, training, and
communication with the sentinel clinical laboratories, first responders, and other stakeholders as a critical role in
jurisdiction-wide emergency management and response.
Notes: Multiple sources were identified as support documents for this domain (21,26,51,53–57). This domain is intended to
be used in conjunction with the Safety and Communication domains and is based on the Federal Emergency Management
Agency's (FEMA) mission areas for national preparedness (55). Critical activities in each phase frequently overlap. This
domain does not address accidents, spills, or other similar occurrences within the laboratory, which are included in the Safety
domain.

Workforce Training Competency Guidelines


Purpose statement: The competencies in Workforce Training address the knowledge, skills, and abilities needed to train
public health laboratory professionals (Table 7). This includes the design, development, implementation, and evaluation of all
types of training.
Introduction: Workforce Training is a process that uses principles of adult learning and instructional design to develop,
manage, deliver, and evaluate internal and outreach education and training activities. Although training services and
resources can be accessed externally, management should also support internal activities to ensure staff members possess the
skills and knowledge to carry out their responsibilities in all aspects of their job performance. This domain provides guidance
to staff members on subject matter expertise and project management for the development and delivery of training.
As persons are an organization's most valuable asset, having well-trained staff members at all functional levels improves
organizational performance and ensures the success of the laboratory in providing services to address public health concerns.
Notes: Sources were identified as support documents for this domain (36,58). This domain is intended for the general
laboratory scientist and not solely for education or training specialists or subject matter experts. The competencies apply to
all types of training modalities.

General Laboratory Practice Competency Guidelines


Purpose statement: The competencies in General Laboratory Practice address the knowledge, skills, and abilities needed
to fulfill basic responsibilities for performing sample analyses within a public health laboratory setting (Table 8).
Introduction: General laboratory practice is the set of foundational knowledge and capabilities needed for the testing of
samples across the wide spectrum of scientific and technical activities of public health laboratories. As these practices can be
applied in many areas of analysis, they have been consolidated into this domain to minimize, but not eliminate, repetition
across the specialized domains and to create a domain that covers testing not specifically encompassed by the Chemistry or
Microbiology domains.
These broad practices are central to the performance of laboratory testing. Laboratory scientists, regardless of their specific
area of scientific or technical expertise, rely on these skills to accomplish the array of testing in public health laboratories.
Notes: Sources were identified as support documents for this domain (59,60), which is intended for both general and
specialized laboratory scientists. This domain is meant to be used in conjunction with specialized domains such as

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Microbiology, Chemistry, and Research since it includes technical practices not addressed in those domains. The verb
"oversees" is used extensively in the Expert level. In this context, "oversees" is a broad term that comprises the many
functions related to the management of policies, processes and procedures to include creation, design, development,
directing, monitoring, evaluation, and collaboration.

Safety Competency Guidelines


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

Potential Hazards, which addresses the knowledge, skills, and abilities needed to recognize potential hazards within a
given laboratory setting;
Hazard Control, which addresses the knowledge, skills, and abilities needed to support and maintain a health and safety
management system to control or prevent workplace hazards;
Administrative Controls, which addresses the knowledge, skills, and abilities needed to develop a laboratory safety
program that is compliant with regulatory, accreditation, and licensing requirements;
Communication and Training, which addresses the knowledge, skills, and abilities needed to ensure staff members are
informed of all safety hazards through effective communication and the provision of related education and training; and
Documents and Records, which addresses the knowledge, skills, and abilities needed to document activities related to
safety policies, processes, and procedures.

Introduction: Safety focuses on the occupational and personal safety of staff members and the environments in which they
work. A culture of safety encourages reporting of actual and potential situations which might place staff members and others
at risk, openly assesses those risks, and implements redundant systems to keep risk to the absolute minimum. It is essential
that leadership and management staff members ensure a comprehensive safety culture for those working in the public health
laboratory.
A safety culture is fundamental to ensuring the protection of the laboratory facility, its staff, and the surrounding
environment from hazards and risks related to laboratory operations and services. Safety is the background against which all
staff members must perform all aspects of their job. A culture of safety recognizes that to err is human, and establishes
procedures and processes to minimize errors and avoid harm. To be effective, all staff members are expected to be part of the
culture of safety.
This domain is based on the 2011 "Guidelines for Biosafety Laboratory Competency" (26), with the content revised and
restructured to fit within this comprehensive set of public health laboratory competencies. This domain supplements and
expands upon the 2011 Guidelines. Some reformulation of concepts from the former "Midlevel" and "Senior level" tiers were
introduced here to ensure a wider breadth of bench-level and managerial responsibilities. However, the 2011 Biosafety
Laboratory Competencies include critical task-level details that could not be captured here due to the directives for
competency development that were adopted. The 2011 Guidelines are, therefore, an important companion to this domain.
Note: Multiple sources were identified as support documents for this domain (26,51,52,61–74).

Surveillance Competency Guidelines


Purpose statement: The competencies in Surveillance address the knowledge, skills, and abilities required for the
collection and analysis of data to support public health decision making to ensure the health of the community (Table 10).
This includes continuous laboratory testing, data compilation, and data dissemination on infectious organisms, chemical
analytes, radiological materials, and evidence of hereditary anomalies.
Introduction: Surveillance is the continuous, systematic collection, analysis, and interpretation of health-related data
needed for the planning, implementation, and evaluation of public health practice (75). With surveillance, the spread of
disease (i.e., any condition that causes injuries, disabilities, disorders, syndromes, infections, or symptoms) is monitored to
establish patterns of progression to predict, observe, and minimize the harm caused by the disease. Well-developed
surveillance capacity is the foundation on which health departments detect, evaluate, and design effective responses to public
health threats. Laboratory information and services are essential to public health surveillance, as the collection, validation,
analysis, interpretation, dissemination, and use of laboratory-generated results are crucial to target public health prevention
and ensure the health of communities. Public health laboratory scientists and epidemiologists need to work closely to ensure
effective population-based disease control and prevention. Effective laboratory reporting to epidemiologists, providers, or
other submitters also requires an electronic laboratory reporting (ELR) system that is interoperable with electronic health
records and notifiable condition reporting for both care and surveillance.
The public health laboratory plays a unique role in public health surveillance by providing crucial information on the
appropriate samples and testing methods, by identifying harmful substances and agents, and by providing the ability to
investigate and communicate unusual findings. It is essential for laboratory staff members to understand both their
individual role and the laboratory's role in surveillance, testing, reporting, and disease and exposure monitoring.
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Notes: Multiple sources were identified as support documents for this domain (15,75–77). Because all public health
laboratory testing has a direct or indirect impact on surveillance, this domain is intended for all staff members and not just
for persons involved in dedicated surveillance activities.

Informatics Competency Guidelines


Purpose statement: The competencies in Informatics address the knowledge, skills, and abilities needed to systematically
apply information science, computer science, and information technology to support public health practice, research, and
learning (Table 11).
Introduction: Informatics is a broad field encompassing information science, information technology, algorithms, and
social science. In addition to electronic recordkeeping and automated data management, informatics includes such activities
as test analyses, clinical decision support, messaging, and knowledge management. Once thought of as a support function, the
delivery of laboratory informatics services has now evolved to be a mission-critical and central component of laboratory
operations.
Informatics is critically important to the public health laboratory's role in protecting the public from infectious diseases,
environmental dangers, and other health threats. Public health laboratory informatics must be cross-cutting and
interoperable to support a nationally integrated electronic laboratory reporting (ELR) system and electronic health record
(EHR) system. Since all laboratories must rely on informatics capabilities and often have limited access to informaticians or
informatics specialists, it is essential that all staff members maintain varying levels of informatics competencies.
Notes: Multiple sources were identified as support documents for this domain (20,78–81). In particular, the competencies
defined in this domain are based on the content and framework of a 2013 comprehensive public health laboratory informatics
self-assessment tool (78). In turn, this tool was framed on an earlier document (79) outlining consensus on the business
requirements of laboratory information management systems. Some of the competencies provided in these guidelines,
particularly the Expert level, might appear beyond the reach of the typical bench scientist. While laboratory scientists might
initially have competencies limited to the Beginner or Competent level, a long-term goal is to ensure that public health
laboratories have within their ranks scientists with competencies at the Proficient and Expert levels. This domain includes
paper systems as part of the laboratory information system.

Microbiology Competency Guidelines


Purpose statement: The competencies in Microbiology address the knowledge, skills, and abilities needed to safely and
securely detect, identify, and report infectious agents of concern to the public while following the laboratory path of workflow
(Table 12).
Introduction: Microbiology is the scientific study of microorganisms and infectious agents as applied to the diagnosis,
treatment, and prevention of disease, disability, and death. Microbiology includes the subspecialties of virology, mycology,
parasitology, mycobacteriology and bacteriology that are encompassed in the disciplines of clinical, food, and environmental
microbiology.
Microbiology is critical to the public health role of detecting and identifying outbreaks, emerging diseases, and biological
threats. Public health laboratories serve many public health programs and provide reference and specialized testing that
relate to disease control and prevention in the population. The testing services address multiple modes of transmission and
include molecular methods for epidemiology and disease surveillance. In addition, public health laboratories provide many
specialized tests that are not commercially available.
Notes: Multiple sources were identified as support documents for this domain (26,51,59,61,62,82). This domain is not
expected to be all-inclusive of functions performed in every microbiology subspecialty in the laboratory. The General
Laboratory Practice and Safety domains are companions to this domain; all are intended to be used together, though some
overlap in content exists. The verb "oversees" is used extensively in the Expert level. In this context, "oversees" is a broad
term that comprises the many functions related to the management of policies, processes and procedures to include creation,
design, development, directing, monitoring, evaluation, and collaboration. There is an assumption for the Beginner level,
especially with use of the verbs "performs" and "adheres to," that there is a degree of training and supervision still occurring
that is providing needed guidance and information (e.g., on why it is critical to perform steps and processes as directed).

Chemistry Competency Guidelines


Purpose statement: The competencies in Chemistry address the knowledge, skills, and abilities needed for the qualitative
and quantitative analysis of chemicals of concern to the public in biological and environmental matrices (Table 13).
Introduction: Chemistry is the science of detection, measurement, and characterization of chemicals of public health
importance in samples (e.g., human and animal, food and feed, water and soil). Chemistry encompasses numerous
subdisciplines in areas of both organic and inorganic testing.

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Chemistry programs within public health laboratories provide a first line of defense in the rapid recognition of toxic chemical
exposures and also support environmental health and epidemiological programs that investigate human exposures to
chemicals in the environment. Chemistry programs also provide a wide array of specialized services related to clinical
diagnostics for evaluating individual health, identification of environmental health issues, and investigation of population
exposures through epidemiological programs' studies. They also aid in the response to chemical emergencies or chemical
terrorism events by providing rapid and definitive testing to identify and quantify chemical agents.
Notes: Sources were identified as support documents for this domain (60,83). This domain is not expected to be all-inclusive
of all chemistry-related laboratory activities. The General Laboratory Practice and Safety domains are companions to this
domain; all are intended to be used together, though some overlap in content exists. The verb "oversees" is used often in the
Expert level. In this context, "oversees" is a broad term that comprises the many functions related to the management of
policies, processes and procedures to include creation, design, development, directing, monitoring, evaluation, and
collaboration. There is an assumption for the Beginner level, especially with use of the verbs "performs" and "adheres to," that
there is a degree of training and supervision still occurring that is providing needed guidance and information (e.g., on why it
is critical to perform steps and processes as directed).

Bioinformatics Competency Guidelines


Purpose statement: The competencies in Bioinformatics address the knowledge, skills, and abilities needed to collect,
classify, and analyze biological and biochemical information through the development and use of computer databases,
algorithms, and statistical techniques (Table 14).
Introduction: Bioinformatics is the field of science that bridges the gap between biology, computer science, and
information technology by merging them into a single discipline. There are three important subdisciplines within
bioinformatics: the development of new algorithms and statistics with which to assess relationships among members of large
data sets; the analysis and interpretation of various types of data including nucleotide and amino acid sequences, protein
domains, and protein structures; and the development and implementation of tools that enable efficient access and
management of different types of information.
Bioinformatics capability and capacity have become progressively more important within public health laboratories because
of rapid advances in molecular technologies and laboratory techniques. As a result, the amount of data that a typical
laboratory can generate has increased dramatically over the past decade. This increase in data requires new competencies for
laboratory scientists to analyze and interpret large datasets, and communicate complex and complete results to audiences of
varied backgrounds.
Notes: Sources were identified as support documents for this domain (84,85). This domain is intended for all laboratory
scientists in addition to bioinformatics specialists.

Research Competency Guidelines


Purpose statement: The competencies in Research address the knowledge, skills, and abilities needed to conduct a
systematic, hypothesis-driven investigation that includes research development, testing, and evaluation designed to advance
public health knowledge, methods, and/or practice (Table 15).
Introduction: Research is a systematic investigation designed to develop or contribute to generalizable knowledge. It also
includes product or method development, assessment, and evaluation. Scientific research provides information to solve new
or existing problems, to reaffirm results of previous work, and to support or develop new hypotheses.
Research is critical to the public health enterprise, as communities are continually challenged with new diseases and
unknown environmental public health threats. The public health laboratory community is also challenged by changes in
virulence or drug susceptibility of pathogens, which impact exposure investigation and response, and the need for advanced
diagnostics and analyses to support surveillance.
Notes: Multiple sources were identified as support documents for this domain (41,44,86,87). This domain is intended for use
in conjunction with the General Laboratory Practice and Safety domains. The verb "oversees" is used extensively in the Expert
level. In this context, "oversees" is a broad term that comprises the many functions related to the management of policies,
processes and procedures to include creation, design, development, directing, monitoring, evaluation, and collaboration. This
domain does not address areas of assessment and evaluation of laboratory practices, which is included in the Quality
Management System and Management and Leadership domains.

Conclusion
These competency guidelines outline the knowledge, skills, and abilities needed by the PHL workforce to fulfill the
responsibilities of, and demands on, the PHL system. They were developed with consideration of the diversity and complexity
of PHLs. The competencies should serve as a foundation for workforce development efforts to identify and support training
standards and performance expectations; develop standardized job descriptions; periodically assess individual staff and
organizational capacity; and develop and implement training plans with the competencies as a guide. The competency
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guidelines might also be used as a framework for developing progressive job series (career ladders) for PHL workers, which
has been identified as a significant barrier to worker recruitment and retention (6–8).
CDC and APHL recognize the existence of possible obstacles and challenges that might affect the implementation of these
competencies. Although the uses and benefits of implementing the competencies are numerous, their adoption by PHLs
might be affected by organizational and resource constraints. Acceptance and adoption of competencies in a workplace
require ongoing leadership support for successful assimilation of competencies into human resources processes such as job
descriptions or for integration into the curriculum of the laboratory's training and continuing education programs. Because
most laboratories' human resource functions are managed by an ancillary department outside the laboratory, a collaborative
effort will be needed to weave competencies into the performance management systems and hiring processes. There is also a
need to educate laboratory professionals about the value of applying competencies to their daily work and a need for
understanding how competencies can be used as a career ladder and management tool. On the basis of experience with the
biosafety laboratory competencies published in 2011 (26), it might take several years before competencies are integrated into
daily work practices (16). Successful assimilation of these competency guidelines will depend on the resources available to
fully adopt and implement them and on the receptivity of laboratory professionals across the spectrum of job positions and
titles. Sustained effort in these areas will be critical to strengthening the workforce and its ability to support and manage the
national laboratory system.

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

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

BOX. Timeline for development of the competency guidelines

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

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April 2014: The Harmonization of Domains Workgroup reviewed major changes made by the Domain Teams to the draft
competencies in response to reviewer comments and resolved remaining redundancies and inconsistencies in approach and
language among the competency domains.
April–July 2014: Small teams from the Harmonization of Domains Workgroup finalized the competency domains.
October 2014: The CDC/APHL Steering Committee reviewed the competency guidelines.
February 2015: CDC reviewed and approved the final guidelines.

FIGURE. Schematic of competency domains for public health laboratory professionals*

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

TABLE 1. Public health laboratory competency guidelines: Quality Management System (QMS) domain

QMS 1.00. Organization: ensures that the laboratory's organizational structure is committed to achieving
and maintaining quality*

Subcompetency Beginner Competent Proficient Expert

Sustains laboratory
Demonstrates actions quality management Oversees the development of
QMS 1.01. Describes quality
consistent with quality system (QMS)* processes policies,* processes,* and
Commitment to concepts and good
concepts and good and procedures to ensure procedures* for review and
quality professional practice
professional practice good professional maintenance of the QMS
practice

Coordinates organizational
Identifies the Explains how the
QMS 1.02. Manages organizational structure to ensure the QMS
laboratory's laboratory's
Organizational structure to ensure is well-integrated into all
organizational structure organizational structure
structure quality levels of laboratory
that ensures quality ensures quality
operations

QMS 1.03. Quality Describes the culture, Adheres to the culture, Advocates for a culture of Fosters a culture of quality,

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culture programs, and programs, and quality, safety, and ethics safety, and ethics
communication communication
processes regarding processes regarding
quality, safety, and quality, safety, and
ethical practices* ethical practices

Ensures the ability to


Identifies resources Makes resource allocation
QMS 1.04. Requests resources to respond to unanticipated
used to support the decisions to support the
Resources support the QMS needs for resources to
QMS QMS
support the QMS

Creates an action plan to


Describes how cost Analyzes quality address the impact of quality
Develops the procedures
QMS 1.05. Cost of effective quality measures to evaluate costs on regulatory
to estimate and compare
quality* measures can improve the costs of maintaining compliance, customer*
quality costs
laboratory performance quality service, and the operating
budget

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS)
domain

QMS 2.00. Customer focus: ensures that customer needs, expectations, and requirements* are consistently
met

Subcompetency Beginner Competent Proficient Expert

Recognizes the Analyzes feedback and


QMS 2.01. Responds to internal Oversees the system for
laboratory's internal satisfaction data from
Customer and external customer measuring customer and user
and external internal and external
satisfaction inquiries and feedback satisfaction
customers customers

Describes the
Oversees the policies,
customer services Adheres to roles and
Develops procedures to processes, and procedures for
provided by the responsibilities in
QMS 2.02. address customer needs, providing customer services
laboratory to meet meeting customer
Customer services expectations, and that meet customer needs,
customer needs, needs, expectations,
requirements expectations, and
expectations, and and requirements
requirements
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

Participates in
Oversees the policies,
required workplace Manages work area to
Develops site-specific processes, and procedures to
QMS 3.01. training regarding ensure staff
workplace safety policies develop, review, and maintain
Workplace safety safety and compliance with
and procedures a safety plan that meets
maintenance of the safety requirements
requirements
physical environment

Monitors
Describes the Ensures security and
environmental
laboratory design, containment of staff, Directs the process and
QMS 3.02. controls* for good
escape routes, and samples,* laboratory planning for facility design,
Facilities laboratory practice
workplace supplies, and laboratory modification, and renovation
and testing
accommodations equipment*
capabilities

QMS 3.03. Waste Describes waste Applies waste Trains staff on the waste Ensures the waste
management management policies, management policies, management plan,* management plan follows
processes, and processes, and including recycling and regulatory requirements
procedures disposal methods

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procedures to
activities

Trains staff in the


Explains own role in emergency
QMS 3.04. emergency event management plan for Provides input on Establishes emergency
Emergency mitigation, emergency event emergency management management and response
management and preparedness, mitigation, and response policies, policies, processes, and
response response, and preparedness, processes, and procedures procedures
recovery response, and
recovery

QMS 4.00. Personnel: ensures recruitment and retention of a qualified, well-trained, and competent
workforce

Subcompetency Beginner Competent Proficient Expert

Ensures each position has Designs a process to


Describes education, Describes process the required competencies, determine required
QMS 4.01. Staff
training, and skills required to verify staff education, training, skills, competencies, education,
qualification
required for job qualification and experience, and where training, skills, experience and
process
performance competency applicable, certification,* where applicable, certification
and licensure* and licensure for each job title

Ensures orientation
QMS 4.02. Participates in
and end-of- Facilitates orientation and
Orientation and orientation and end- Designs an orientation and
employment processes end-of-employment
end-of- of-employment end-of-employment program
are carried out for processes
employment processes
each staff person

Ensures that training


Oversees the policies,
QMS 4.03. Participates in and evaluation are Facilitates training and
processes, and procedures for
Training required training carried out for evaluation processes
the training program
assigned duties

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

Participates in the
QMS 4.04. development of an Evaluates individual Oversees a competence
Describes competence
Competence individualized competence assessment assessment plan for the
assessment plans
assessment plan competence plans organization
assessment plan

Participates in Manages the plan to


Designs a plan to provide
QMS 4.05. Participates in initial training continuing education provide professional
professional development
Professional related to assigned work and professional development
opportunities to all levels
development plan position development opportunities to all levels
of staff
opportunities of staff

QMS 4.06. Participates in the initial Participates in the Establishes a process for
Manages the performance
Performance performance evaluation ongoing performance periodic performance
evaluation process
evaluation process process evaluation process evaluation

QMS 4.07. Describes the recruitment Participates in Manages the recruitment, Develops recruitment,
Recruitment, and retention plan recruitment and retention, and succession retention, and succession
retention planning plans

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retention, and plans to maintain a


succession plans qualified workforce

QMS 5.00. Purchasing and inventory: ensures that requirements for supplies and services are consistently
met

Subcompetency Beginner Competent Proficient Expert

Ensures that laboratory


QMS 5.01. Describes laboratory Participates in procurement incorporates
Manages laboratory
Procurement procurement process for laboratory organizational rules and
procurement process
process current work area procurement process collaboration with
purchasing authorities

Follows established
Develops inventory
inventory
QMS 5.02. Describes the inventory processes for laboratory
management Oversees inventory
Inventory management processes used supplies, reagents, and
processes, including management plan
processes in current work area verification* of
receipt and
performance
inspection processes

Executes the process Develops a process to


to evaluate and evaluate the satisfaction
QMS 5.03. Describes the process to Oversees a quality
provide feedback to with services and
Evaluation evaluate and provide improvement plan for
suppliers, products from suppliers,
process feedback to suppliers purchasing and inventory
consultants, and consultants, and
contractors contractors

QMS 6.00. Laboratory equipment: ensures that laboratory equipment selection, installation, use,
maintenance, and troubleshooting meet performance standards

Subcompetency Beginner Competent Proficient Expert

Provides input on the


Describes the policies, processes and Develops the processes Oversees the policies,
QMS 6.01.
processes, and procedures for procedures for and procedures for processes, and procedures
Acquisition and
equipment acquisition and equipment equipment acquisition for equipment acquisition
decommissioning
decommissioning acquisition and and decommissioning and decommissioning
decommissioning

Performs equipment
Describes processes and
QMS 6.02. installation, Oversees the policies,
procedures for equipment Implements the
Equipment operational, and processes, and procedures
installation qualification, equipment qualification
qualification performance regarding the equipment
operational qualification, and plan
plan* qualification qualification plan
performance qualification
procedures

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

Describes processes and Develops the


Performs procedures
procedures for the processes for Oversees the policies, processes,
QMS 6.03. for the maintenance,
maintenance, equipment and procedures for equipment
Maintenance troubleshooting, and
troubleshooting, and maintenance, maintenance, troubleshooting,
process service and repair of
service and repair of troubleshooting, and service, and repair
equipment
equipment service and repair

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QMS 6.04. Describes calibration of Performs calibration Establishes Oversees calibration policies,
Instrument and instruments and of instruments and calibration processes processes, and procedures for
equipment equipment equipment and procedures for instruments and equipment
calibration instruments and
equipment

QMS 7.00. Process management:* ensures that operational processes meet organizational requirements

Subcompetency Beginner Competent Proficient Expert

Applies workflow Develops evaluation, Oversees the policies, processes


QMS 7.01. Describes workflow processes according modification, and and procedures for evaluating and
Workflow† processes related to job to laboratory policies, design of workflow modifying current workflow
processes position and activities processes, and processes and processes and for developing new
procedures procedures workflow processes

Describes how processes Participates in


QMS 7.02. Develops the process
are controlled in work process control Oversees the process control plan
Process control control plan
area procedures

QMS 7.03. Develops method


Oversees the policies, processes,
Method Describes method Performs procedures validation and
and procedures for validation of
validation* and validation and for method validation performance
new or modified tests or materials
performance performance verification and performance verification
and for verification of existing
verification processes verification processes and
tests or materials
processes procedures

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

Develops the
Applies the policies, Oversees the document
QMS 8.01. policies, processes,
Describes how the processes, and management system to ensure
Document and procedures for
laboratory controls and procedures for staff compliance with internal
management controlling and
manages documents controlling and policies, external regulations, and
system managing
managing documents accreditation* requirements
documents

Applies the policies, Develops the Oversees the record management


QMS 8.02.
Describes how the processes, and policies, processes, system to ensure staff compliance
Records
laboratory controls and procedures for and procedures for with internal policies, external
management
manages records controlling and controlling and regulations, and accreditation
system
managing records managing records requirements

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS)
domain

QMS 9.00. Information* management: ensures the confidentiality,* security, and integrity of generated
and disseminated information

Subcompetency Beginner Competent Proficient Expert

Describes the policies, Develops policies,


Complies with policies, Oversees the policies,
processes, and processes, and
processes, and procedures processes, and procedures for
procedures for procedures for
QMS 9.01. for maintaining ensuring confidentiality of
maintaining maintaining
Confidentiality confidentiality of information and staff
confidentiality of confidentiality of
internally and externally compliance with regulations
laboratory internally and externally
derived information and guidelines
information derived information

QMS 9.02. Describes the policies, Complies with policies, Develops policies, Oversees the policies,

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Security processes, and processes, and procedures processes, and processes, and procedures for
procedures related to for securing information procedures to ensure securing information,
securing information information is secure including audits to meet
related to assigned job regulations and guidelines
tasks

Describes the policies,


Complies with policies, Oversees the policies,
QMS 9.03. processes, and Develops processes and
processes, and procedures processes, and procedures to
Information procedures for procedures to ensure the
to ensure the integrity of ensure the integrity of
integrity ensuring integrity of integrity of information
information 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.
Investigates NCEs, Oversees the policies,
Management of
Recognizes NCEs Responds to NCEs including the creation of processes, and procedures
nonconforming
a corrective action plan related to NCEs
events (NCEs)

Oversees the policies,


Describes the policies, processes, and procedures to
QMS 10.02. Performs analysis of
processes, and document NCEs and report
Documentation of Reports discovered NCEs records and reports of
procedures to record NCE information to senior
NCEs NCEs to identify trends
and report NCEs management and external
entities

Oversees the policies,


QMS 10.03. Leads the process of Assesses NCE
Participates in NCE processes, and procedures for
Investigation and investigating NCEs and investigations and root
investigations and investigating NCEs and
root cause performing root cause cause analyses to
root cause analyses performing root cause
analysis* analyses improve processes
analyses

Describes the policies,


Develops processes and Oversees the policies,
QMS 10.04. processes, and
Responds to product procedures to address processes, and procedures to
Notifications of procedures to address
recalls and technical product recalls and address product recalls and
recalls and product recalls and
bulletin notifications technical bulletin technical bulletin
technical bulletins technical bulletin
notifications notifications
notifications

QMS 11.00. Assessments: ensures that processes are in place to perform internal audits* and external
assessments*

Subcompetency Beginner Competent Proficient Expert

Ensures the application of


QMS 11.01.
Adheres to the quality the quality assessment Develops the quality Oversees a comprehensive
Quality
assessment plan plan to laboratory assessment plan quality assessment plan
assessment* plan
operations

Develops the processes Oversees the policies,


QMS 11.02. Participates in
Performs external and procedures to select, processes, and procedures
External external assessment
assessment procedures enroll, and participate in related to external
assessments activities
external assessments assessment

Develops the processes Oversees the policies,


QMS 11.03. Participates in Performs internal audit
and procedures for processes, and procedures
Internal audits internal audits procedures
internal audits related to internal audits

TABLE 1. (Continued) Public health laboratory competency guidelines: Quality Management System (QMS)

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domain

QMS 11.00. Assessments: ensures that processes are in place to perform internal audits* and external
assessments*

Subcompetency Beginner Competent Proficient Expert

Describes the Develops processes and


Employs pre-
elements of pre- procedures for determining Oversees the policies,
QMS 11.04. examination,
examination,* pre-examination, processes, and procedures
Quality examination, and
examination,* and examination, and related to developing and
indicators* postexamination
postexamination* postexamination quality assessing quality indicators
quality indicators
quality indicators indicators

Describes the Complies with


Oversees the policies,
QMS 11.05. policies, processes, policies, processes, Develops the processes and
processes, and procedures
Quality indicator and procedures and procedures procedures for collecting
related to the collection and
data collection related to collecting related to collecting and analyzing quality
analysis of quality indicator
and analysis and analyzing quality and analyzing quality indicator data
data
indicator data indicator data

QMS 12.00. Continual improvement: ensures mechanisms for continuous quality improvement

Subcompetency Beginner Competent Proficient Expert

QMS 12.01. Describes the


Oversees the policies,
Continuous policies, processes, Implements changes Develops the processes and
processes, and procedures
Quality and procedures identified through procedures of the CQI
related to the quality
Improvement related to the CQI the CQI program program
improvement program
(CQI)* program program

Follows CQI
processes and Documents staff compliance
procedures for with CQI activities that Oversees the policies,
QMS 12.02. CQI Participates in CQI
troubleshooting and support the CQI monitoring, processes, and procedures
activities activities
documenting evaluation, and review related to CQI activities
required CQI processes
activities

Describes the
Implements the Develops corrective action
QMS 12.03. policies, processes, Oversees the policies,
processes and processes and procedures to
Corrective action* and procedures processes, and procedures
procedures related to address quality
process related to corrective related to corrective action
corrective action improvement
action

Describes the
Implements the
policies, processes, Develops the processes and Oversees the policies,
QMS 12.04. processes and
and procedures procedures related to processes, and procedures
Preventive action* procedures related to
related to preventive preventive action related to preventive action
preventive action
action

Implements the change Oversees activities related to


Describes the process Participates in the management process, policy, process, and procedural
QMS 12.05.
to change laboratory process and including communication of change management, including
Change
policies, processes, procedures related to changes made to established evaluation of impact on
management*
and procedures change management policies, processes, and organizational processes and
procedures 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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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

Aligns personal Creates a culture where


Coaches staff in
ETH 1.01. integrity with Exemplifies integrity in integrity is the foundation
behaviors that exemplify
Personal integrity organizational interactions and activities for all interactions and
integrity
culture activities

Ensures staff compliance


Applies ethical Oversees the policies,
Serves as a role model of ethical with policies and
ETH 1.02. principles and processes,* and procedures*
behavior by consistently procedures related to
General ethical professional related to ethical principles
conforming to the highest ethical principles and
practices* rules of conduct and professional rules of
ethical standards and practices professional rules of
to the workplace conduct
conduct

Oversees the policies,


Acts as a good Ensures that the use of
ETH 1.03. processes, and procedures
steward of Identifies methods to improve public funds and
Stewardship of to ensure the environment
public funds and stewardship of resources resources meet the
resources supports excellence in the
resources policies for stewardship
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

Verifies Ensures staff compliance Oversees the policies,


Instructs others in policies,
ETH 2.01. scientific with policies and processes and procedures to
processes, and procedures
Scientific integrity of test procedures regarding ensure practices are
regarding scientific integrity of
integrity* results and scientific integrity of all consistent with guidelines
test results and findings
findings results and findings on scientific integrity

Serves as a role model of


Applies Ensures staff compliance
scientific ethical behavior and Oversees the policies,
scientific ethics with policies and
ETH 2.02. rules of conduct by consistently processes, and procedures
and rules of procedures related to
Scientific ethics conforming to the highest related to scientific ethics
conduct to the scientific ethics and rules
scientific standards and and rules of conduct
workplace of conduct
practices

* This term is defined in Appendix B.

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

MLD 1.00. General management: ensures sound management of laboratory operations

Subcompetency Beginner Competent Proficient Expert

Contributes to Explains the


MLD 1.01. activities that relationships between Exemplifies the mission,
Develops the mission, vision
Mission, vision, support the mission, activities that support vision and values for the
and values for the laboratory
and values vision, and values of the mission, vision, and laboratory
the laboratory values

Adapts organizational Oversees a process* to ensure


Describes the Coordinates laboratory
MLD 1.02. structure to meet the organizational structure meets
organizational program* structure to
Organizational laboratory's mission and the laboratory's mission and
structure of the meet organizational
structure directives for laboratory directives for laboratory
laboratory needs
programs programs

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MLD 1.03. Laws Complies with laws Coordinates program Manages laboratory Ensures that laboratory
and regulations and regulations activities according to programs consistent with programs are consistent with
for laboratory related to laboratory laws and regulations laws and regulations federal, state, and local laws
operation operations related to laboratory related to laboratory and regulations
operations operations

Oversees the policies,*


MLD 1.04. Works
Develops processes and processes, and procedures*
Technical collaboratively on Implements technical
procedures to manage related to the development and
operations technical and and operational plans
technical operations evaluation of technical
management operational planning
operations

Operates within
MLD 1.05. Manages the emergency
Describes emergency assigned roles when Oversees laboratory-wide
Emergency management and
management policies carrying out emergency emergency management and
management and response plan at the
and procedures management and response
response programmatic level
response duties

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

Describes the
Oversees funding and
MLD 1.06. processes for Manages the
Participates in stakeholder relationships
Analytical and introducing improvement of
improvement of analytical needed to implement and
operational improved analytical analytical and
and operational services improve analytical and
services and operational operational services
operational laboratory services
services

Explains the importance of Oversees the policies,


MLD 1.07. Evaluates the quality of
Describes quality providing quality processes, and procedures to
Quality* testing services for continued
principles laboratory testing and ensure the quality of
and services quality improvement
services laboratory testing and services

Oversees the policies,


Identifies strategies and
MLD 1.08. Supports customer Evaluates customer service processes, and procedures to
activities to improve
Customer* service service needs satisfaction and trends ensure the laboratory
customer service
maintains a customer focus

Uses basic project Directs the management


MLD 1.09. Project Trains staff on project Oversees project management
management of projects at the
management* management techniques across the laboratory
concepts* and tools programmatic level

Contributes data Oversees the policies,


Analyzes data to assist in Directs activities to
MLD 1.10. for program processes, and procedures
the monitoring and monitor and evaluate
Program effectiveness regarding the measurement,
evaluation of program the effectiveness of
effectiveness monitoring and analysis, and improvement of
effectiveness laboratory programs
evaluation program effectiveness

MLD 2.00. Policy development: ensures the development, implementation, and review of internal policies

Subcompetency Beginner Competent Proficient Expert

Compiles important issues, Prepares internal


Describes concepts
MLD 2.01. lists of stakeholders, and policies based on
pertinent to Oversees the internal policy
Internal policy various options and evaluation of short- and
developing internal development process
development solutions for internal long-term consequences
policies
policy development of potential policies

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MLD 2.02. Complies with Implements internal Ensures staff compliance Oversees internal policy
Internal policy documented policies for a laboratory with laboratory-wide implementation and staff
implementation internal policies program policies compliance
and guidelines

Reviews internal
MLD 2.03.
policies for Develops amendments or Evaluates internal Oversees the review process
Internal policy
revisions and updates to internal policies policies for internal policies
review
updates

MLD 3.00. Financial management: ensures sound financial management

Subcompetency Beginner Competent Proficient Expert

Oversees budgets, including


Complies with Reconciles budget,
MLD 3.01. Monitors staff compliance development and staff
budgetary expenditures, and
Budgets to the budget compliance with agency and
guidelines income
legislative mandates

Describes revenue
MLD 3.02. Manages revenue and
sources associated Tracks revenue and income Ensures that necessary
Revenue and income for the
with individual for a laboratory program revenue and income is secured
income laboratory
activities

Adheres to
Ensures staff compliance Oversees the policies, process,
MLD 3.03. guidelines and Tracks expenditures for a
with guidelines and and procedures related to the
Expenditures limits for laboratory program
limits for expenditures cost of operations
expenditures

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

Integrates
MLD 3.04. financial Oversees the policies, processes,
Uses designated Optimizes the financial
Financial management and procedures related to financial
financial management management system for
management tools for a management and fiduciary
tools the laboratory
process laboratory responsibility
program

Optimizes use of
MLD 3.05. Oversees the policies, processes,
Uses workplace laboratory Manages resources for the
Resource and procedures related to resource
resources efficiently program laboratory
management management
resources

MLD 4.00. Human resource management: ensures effective management of human resources

Subcompetency Beginner Competent Proficient Expert

Enforces human
MLD 4.01. Complies with human Oversees the policies, processes,
resource Manages human resource
Human resource resource rules and and procedures related to the
requirements requirements and policies
policies requirements* human resource system
and policies

MLD 4.02. Equal


Promotes EEO Oversees the policies, processes,
Employment Describes the EEO Manages EEO
requirements and procedures related to EEO in
Opportunity process requirements and policies
and policies the human resource system
(EEO)* process

MLD 4.03. Provides input into job Evaluates Manages the development Oversees a system of position
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Position description content position and implementation description development and


descriptions descriptions for processes for position implementation to maximize staff
congruency with descriptions competence and meet operational
job functions requirements

Describes the basic Maintains a


education, skills and process to Performs ongoing gap
MLD 4.04. Staff Ensures staff compliance with
certifications* for ensure that staff analysis to address staff
licensure* licensure laws and regulations
laboratory staff meet licensure licensure requirements
licensure requirements requirements

Manages the
MLD 4.05. Participates in Ensures that staff competence
competency Evaluates the competency
Competency competency levels are commensurate with job
assessment assessment program
assessment assessments functions
program

Participates in Integrates
MLD 4.06. Monitors staff progress on Ensures that a system is in place
communications with performance
Performance agreed-upon performance that values honest and open
peers and supervisors feedback into
feedback parameters communication about performance
regarding performance work routines

Describes how the Evaluates effectiveness of


MLD 4.07. formal performance Administers the performance appraisal Oversees the continuous
Performance appraisal process performance process in improving improvement of the performance
appraisal process impacts laboratory appraisals laboratory productivity management system
operations and practice

Identifies the need for Resolves Integrates mechanisms to Oversees the policies, processes,
MLD 4.08.
management conflicts in a fair support cooperation and and procedures to ensure the fair
Conflict
intervention in conflict and equitable manage conflict across the and equitable resolution of
resolution
resolution manner laboratory conflicts

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

MLD 4.00. Human resource management: ensures effective management of human resources

Subcompetency Beginner Competent Proficient Expert

Describes the Ensures that the


MLD 4.09. Analyzes the use of
steps of the Administers progressive progressive discipline
Progressive progressive discipline within
progressive discipline system is used to mitigate
discipline the laboratory
discipline process disciplinary issues

Participates in Assesses professional Oversees the policies,


MLD 4.10.
professional Recommends professional development gaps to ensure processes, and procedures
Professional
development development activities and support staff to encourage and address
development
activities competency development professional development

Explains the
Ensures that staff function
policies and
MLD 4.11. Staff Recommends staff for Develops criteria for staff in roles commensurate
procedures
advancement advancement advancement with experience, skill set,
related to staff
and proficiency
advancement

Oversees the policies,


Recognizes the Implements staff
MLD 4.12. Develops succession plans processes, and procedures
importance of development plans that align
Succession that consider current and related to the creation and
succession with the laboratory's
planning future needs implementation of
planning succession plan
succession plans

MLD 5.00. Leadership: models leadership behavior

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Subcompetency Beginner Competent Proficient Expert

Applies ethical Serves as a role model of Ensures staff compliance Fosters the policies,
MLD 5.01. Ethical
principles and a ethical and professional with the policies and processes, and procedures
practices* and
professional code behavior by consistently procedures related to ethical related to ethical practices
professional code
of conduct to the conforming to the highest practices and a professional and a professional code of
of conduct
workplace standards and practices code of conduct conduct

Ensures the open and


Employs active Communicates information Fosters a culture of open
MLD 5.02. frequent exchange of
communication and feedback to colleagues and frequent
Communication communication between
skills and management staff communication
laboratory staff

Describes the Creates a workplace


MLD 5.03. Collaborates with team Leads cross-functional
value of environment that
Teamwork and members within a laboratory teams to accomplish
collaboration in encourages teamwork and
collaboration program projects
the workplace collaboration

Explains the value Develops programs that


MLD 5.04. Fosters a culture where
of having a Promotes a diverse workforce support a culture of
Diversity* culture diversity is valued
diverse workforce diversity

Participates in
Develops programs that Fosters a culture of staff
MLD 5.05. Staff activities to Implements activities that
support a culture of staff engagement and
engagement* support the support staff engagement
engagement commitment
laboratory's goals

Participates in
MLD 5.06. Staff Evaluates the effectiveness of Develops staff recognition Fosters a culture that
staff recognition
recognition staff recognition programs programs ensures staff recognition
programs

Describes the
MLD 5.07. Fosters a culture where
benefits of Develops a pool of potential Establishes coaching and
Coaching* and coaching and mentoring
coaching and coaches and mentors for staff mentoring programs
mentoring* are deeply-rooted
mentoring

Leads critical thinking


Develops basic Applies critical thinking to Fosters an environment
MLD 5.08. activities to achieve
critical thinking develop effective solutions to that integrates critical
Critical thinking* improvements in laboratory
skills problems thinking
processes

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

MLD 5.00. Leadership: models leadership behavior

Subcompetency Beginner Competent Proficient Expert

Applies systems
thinking when Incorporates systems
MLD 5.09. Describes systems Fosters an environment that
approaching thinking into directing
Systems thinking* thinking integrates systems thinking
projects and laboratory operations
problem solving

Integrates strategic
Provides input into
MLD 5.10. thinking into decisions
Describes strategic strategic thinking Fosters an environment that
Strategic and long-term planning
thinking and decision- integrates strategic thinking
thinking* regarding laboratory
making processes
operations

MLD 5.11. Change Describes the value of Implements Leads the development of Fosters a culture that continuously
management* change change change management assesses change opportunities for

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management initiatives with the sustaining the mission


initiatives within a laboratory
laboratory
program

Educates external Identifies gaps in


Develops strategies to engage
stakeholders on the Collaborates with engagement with external
MLD 5.12. external stakeholders to accomplish
mission, vision, and external stakeholders to support
Advocacy the mission, vision, and activities of
activities of the stakeholders the activities of the
the laboratory
laboratory laboratory

Describes impacts of Fosters relationships with strategic


Communicates Promotes external policy
MLD 5.13. external policies partners to secure laboratory-
with stakeholders development to support
External policy related to the inclusive policies consistent with
to exchange policy the organization's mission
development organization's the organization's mission and
input and vision
mission vision

MLD 5.14. Recognizes the need Identifies potential Facilitates participation Fosters partnerships with key
Promotion of the for partnerships to partnerships to of key stakeholders to stakeholders to promote the health
health of promote the health of promote the health promote the health of of populations affected by
populations populations of populations populations laboratory services

* This term is defined in Appendix B.

TABLE 4. Public health laboratory competency guidelines: Communication domain

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

Subcompetency Beginner Competent Proficient Expert

Incorporates tools to Establishes content, style,


COM 1.01. Applies logical
Identifies key messages for organize and present tone, and form for written
Written structure* to written
written communication detailed or complex messages according to
communication communications
information* target audience

Applies language and


Establishes content, style,
tone in oral Selects communication
COM 1.02. Oral Identifies key messages for tone, and form for oral
communications methods* tailored to
communication oral communication messages tailored to target
tailored to target target audience
audience
audience

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

Subcompetency Beginner Competent Proficient Expert

Facilitates dialogue
COM 2.01. Provides undivided Summarizes the Provides feedback exchange through
Dialogue attention to the other dialogue to show based on the dialogue paraphrasing and
exchange participants in a dialogue understanding summary clarification of critical
points

Exhibits open posture and


Applies range of body Exhibits active Incorporates multiple
COM 2.02. facial expression to engage
language cues to listening during the behaviors of engagement
Contextual clues the other participants in a
enhance the exchange dialogue exchange during dialogue exchanges
dialogue

COM 2.03. Provides counterpoints Coaches others in Facilitates respectful


Defers judgment during
Respectful while being respectful techniques of dialogue among
dialogue exchanges
exchange of disagreements respectful exchange participants in the exchange

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

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


directions

Subcompetency Beginner Competent Proficient Expert

Applies knowledge Extrapolates information


COM 3.01.
Follows written acquired from Adapts concepts from written from written text to
Reading
directions written text to text for use in new situations develop new ideas that
comprehension
situations enhance work processes*

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

Subcompetency Beginner Competent Proficient Expert

Selects laboratory's
Describes the Establishes technology
COM 4.01. technology options Evaluates existing and potential
laboratory's and policies* that integrate
Technology to align with technology to align with
partner's technological with the partner's
capability partner's partner's capabilities
capabilities capabilities
capabilities

Evaluates the
Describes employer's Uses designated Manages technology policies
COM 4.02. Use of effectiveness of the
policies and procedures* technology for and procedures used for sharing
technology technology used for
for sharing information sharing information information
sharing information

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


and stakeholders

Subcompetency Beginner Competent Proficient Expert

Displays
Uses tone of voice and
professional Monitors interactions with Establishes policies for
COM 5.01. language tailored to
demeanor in all customers and stakeholders to professional customer
Professional interactions with
situations with ensure they are conducted and stakeholder
attitude customers and
customers and professionally interactions
stakeholders
stakeholders

Determines
Provides information Ensures that information Develops overarching
information needs
COM 5.02. based on policies and exchange policies, processes, system for exchange of
through
Information procedures to meet the and procedures are followed to information to meet the
collaboration with
exchange needs of customers and meet the needs of the customers needs of customers and
customers and
stakeholders and stakeholders stakeholders
stakeholders

COM 5.03.
Information Shares information as Selects information Creates opportunities for
Develops information to share
sharing directed to share sharing information
opportunities

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

Subcompetency Beginner Competent Proficient Expert

Establishes policies,
COM 6.01. Organizes information Creates drafts of processes, and
Revises written reports
Written reports for written reports written reports procedures for written
reports

Establishes policies,
COM 6.02. Oral Organizes information Creates drafts of processes, and
Revises oral presentations
presentations for oral presentations oral presentations procedures for oral
presentations

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

Subcompetency Beginner Competent Proficient Expert

Establishes policies,
COM 7.01. Risk Adheres to the risk
Describes the risk Ensures staff compliance with processes, and
communication communication
communication process the risk communication plan procedures related to the
plan plan
risk communication plan

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

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

Subcompetency Beginner Competent Proficient Expert

Collaborates with agency leaders


Identifies specific Develops emergency
COM 7.02. Lists basic emergency and partners to deliver
emergency information and
Emergency information for target emergency information and
information for messages tailored to
information audience messages tailored to target
target audience target audience
audience

Delivers empathetic Creates empathetic


COM 7.03. Describes empathetic Evaluates empathetic messaging
messaging in high- messaging in high-risk
Empathetic risk risk communication for high-risk situations and
risk situations or situations and
communication concepts emergencies
emergencies emergencies

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

Subcompetency Beginner Competent Proficient Expert

Coordinates Identifies
Describes impact of the opportunities for opportunities to Develops opportunities to
COM 8.01. Public
work of the public health promoting the public promote the public promote the public health
relations
laboratory and system health laboratory and health laboratory and laboratory and system
system system

Supports the Presents Develops


Manages the policies, processes,
COM 8.02. development and communication communication
and procedures regarding
Communication distribution of materials to explain materials to explain
communication materials to
to educate and communication the importance of the the importance of the
explain the importance of the
inform materials about the public health public health
public health laboratory
public health laboratory laboratory laboratory

Incorporates use of
Develops stories that
stories when
convey information Evaluates the impact of
COM 8.03. Shares approved public communicating the
highlighting the storytelling in promoting the
Storytelling health laboratory stories impact of public
impact of public health public health laboratory
health laboratory
laboratory work
work

Implements the Manages the


COM 8.04.
Participates in marketing strategy marketing strategy for Oversees the marketing strategy
Marketing
marketing strategies for the public health the public health for the public health laboratory
strategy
laboratory 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 Adheres to agency media Identifies situations Monitors the Oversees media relations policies
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relations policies relations policies and where agency media application of agency and strategies
and strategies procedures relations policies and media relations
strategies apply policies and strategies

Develops "plain talk" Translates highly technical


Applies "plain talk"
COM 9.02. "Plain Describes the value of language for media concepts using "plain talk" for
during public and
talk"* using "plain talk" and public media and public
media interactions
communications communications

Develops key
Applies key messages Oversees delivery of key
COM 9.03. Key Describes the value of messages for media
during public and messages on complicated, high-
messages using key messages and public
media interactions risk topics
communications

* This term is defined in Appendix B.

TABLE 5. Public health laboratory competency guidelines: Security domain

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

Subcompetency Beginner Competent Proficient Expert

Interprets security
Applies security concepts to adapt Develops security policies,
SEC 1.01. Security Describes security
concepts in support of policies* and processes,* and procedures,
concepts* concepts
organizational goals procedures* to support including security standards
organizational goals

Identifies assets,*
Describes the risk vulnerabilities, and Develops policies, processes, and
SEC 1.02. Risk Manages the risk
assessment process potential threats for procedures regarding risk
assessment† assessment process
and procedures incorporation into risk assessment
analyses

Describes the
Develops policies, processes, and
policies and Manages the
SEC 1.03. Risk Applies risk mitigation procedures regarding risk
procedures implementation of risk
mitigation plans plans mitigation planning and
regarding risk mitigation plans
implementation
mitigation plans

Describes policies, Develops procedures


Implements processes
SEC 1.04. Risk processes, and based on established Develops policies, processes, and
and procedures for risk
mitigation plan procedures for risk processes for risk procedures for risk mitigation plan
mitigation plan
reporting mitigation plan mitigation plan reporting
reporting
reporting 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

Recommends elements Designs laboratory's


Recognizes security Advises organizational leadership
SEC 2.01. Security to be included in the security plan in
risks documented in on the security plan, including
plans security plan to collaboration with
the security plan acceptability of identified risks
address risks subject matter experts

Advises organizational leadership


SEC 2.02. Describes security Evaluates the objectives on selecting security strategies to
Implements the
Security plan plan elements and functions of the protect assets and on monitoring
security plan
implementation applicable to job security system the performance of the security
plan

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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

Describes the
Manages security
policies,
SEC 2.03. operations to ensure
processes, and Monitors security
Security defined protection Oversees security operations
procedures for operations
operations measures are based on
maintaining
the degree of risk
security

Completes
SEC 2.04.
inventory records Creates tools to Develops policies, processes, and
Inventory Audits inventory
to comply with the manage inventory procedures to manage inventory
records* related records
laboratory's records records
to security plans
security plan

Implements processes
SEC 2.05. Develops policies, processes, and
Reports security Evaluates reported and procedures related
Security incident* procedures for security incident
incidents security incidents to security incident
response response and reporting
response and reporting

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

Subcompetency Beginner Competent Proficient Expert

Trains staff on policies,


SEC 3.01. Physical Describes the processes, procedures, Solves difficult and Directs the resolution of major
security physical security and related regulations complex physical conflicts in physical security policy
infrastructure* infrastructure regarding physical security problems and program objectives
security infrastructure

Describes physical Manages the Advises organizational authorities


security access implementation of on methods for enhancing
SEC 3.02. Applies physical
control policies, physical security access effectiveness and efficiency of
Physical security security access control
processes, control policies, physical security access control
access controls* procedures and systems
procedures, and processes, procedures, policies, processes, procedures, and
systems and systems 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

Interprets personnel
Addresses problems or Develops policies, processes, and
SEC 4.01. Describes security concepts to
questions involving procedures that incorporate
Personnel security personnel security adapt processes and
personnel security personnel security concepts into
concepts* concepts procedures to support
concepts personnel security program
organizational goals

Complies with the


SEC 4.02. Implements the Solves difficult and Directs the resolution of major
laboratory's
Personnel security personnel security complex personnel conflicts in personnel security policy
personnel security
program program security problems and program objectives
program

Collects Analyses actions


Determines actions to Develops policies, processes, and
SEC 4.03. information* for regarding personnel
be taken on personnel procedures related to personnel
Investigations personnel security security matters
security investigations security investigations
investigations requiring investigation

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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

Develops policies,
Applies information
processes, procedures,
Describes policies, security concepts, Interprets information security
SEC 5.01. and organizational
processes, and including principles of concepts to adapt policies,
Information standards for
procedures related to confidentiality, processes, and procedures to
security information security to
information security integrity, and support organizational goals
meet organizational
availability (CIA)*
goals

Describes the risks Develops polices,


Identifies risks Implements processes and
associated with the processes, and
associated with the procedures for prioritizing risks
SEC 5.02. Risk laboratory's sensitive procedures for
laboratory's sensitive associated with the laboratory's
identification and information* or identifying, prioritizing,
information and sensitive information and
prioritization technology related to and controlling sensitive
technology, including technology, including the
the job being information and
the methods of control methods of control
performed technology

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

Subcompetency Beginner Competent Proficient Expert

Establishes policies and


Complies with
processes to specify
SEC 6.01. transport security Audits transport Creates transport security
which materials need
Transport security policies, processes, and records procedures
designated levels of
procedures
transport security

* This term is defined in Appendix B.


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

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

EMR 1.00. Mitigation of emergency events: mitigates emergency events

Subcompetency Beginner Competent Proficient Expert

Manages the policies†,


Recognizes potential
Assesses potential Develops the plan to reduce processes†, and procedures†
EMR 1.01. Risk vulnerabilities and
vulnerabilities and risks and ensure against risks in to reduce and ensure
assessment* risks in their work
in the organization the organization against risks in the
area
organization

Implements the Verifies staff compliance


EMR 1.02. Describes the incident response plan with the incident response Manages facility-wide
Incident response incident response while maintaining plan while ensuring the implementation of the
plan† plan safety and security of safety and security of staff incident response plan
staff and facilities and facilities

EMR 1.03. Recognizes Recognizes emergencies Evaluates staff's ability to Creates an environment
Emergency emergencies and and other incidents in recognize emergencies and that supports the
situation other incidents† in the organization that other incidents that should recognition and reporting of
recognition their work area that should be reported be reported emergencies
should be reported
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Collaborates with persons


EMR 1.04.
Recognizes Instructs others on the Evaluates staff's knowledge and agencies to develop
Emergency
significance of alarms significance of alarms of alarm significance site-specific or unique
alarms†
alarm systems

EMR 1.05.
Laboratory
Describes the assets Inventories the assets in Identifies the assets in the Manages the assets in the
assets† important
in their work area the facility facility facility
during an
emergency

Shares findings of the


Interprets data from
EMR 1.06. Summarizes the Assesses emergencies to evaluation of, and responses
evaluation of emergencies to
Evaluation of emergency evaluation determine the extent of to, emergency events with
develop specific response to
emergency events process each incident stakeholders to enhance
each incident
mitigation

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

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

Subcompetency Beginner Competent Proficient Expert

Manages development
Explains the Assists with
and implementation
laboratory's development and Oversees laboratory's emergency
EMR 2.01. of the emergency
emergency response implementation of the response plan, including
Preparation for response plan and
plan† and Continuity laboratory's implementation of the COOP with
emergency events COOP for an
of Operations Plan emergency response external partners
individual area of
(COOP)† plan and COOP
responsibility

Completes higher-level Implements the ICS


Demonstrates
EMR 2.02. FEMA-approved by completing high-
awareness of the ICS
Incident courses to explain the level FEMA-approved Serves at a leadership level in the
by completing a
command system operation and courses and internal ICS
FEMA-approved
(ICS)† management of the training courses and
introductory course
ICS exercises

Contributes to the Conducts emergency Oversees the collaboration with


Participates in
EMR 2.03. development of response training, stakeholder agencies to sponsor
emergency response
Emergency emergency response exercises, and drills in and conduct training, exercises,
training, exercises,
response training training, exercises, and collaboration with and drills, ensuring proper
and drills
drills stakeholder agencies resources are available

Describes
requirements† for Implements Develops internal
Oversees the collaboration with
notification of organizational plans policies and
EMR 2.04. stakeholders and agencies to
emergencies and and policies for procedures for
Emergency develop and implement plans and
other incidents notification of notification of
notification policies for notification of
according to emergencies and other emergencies and other
emergencies and other incidents
organizational plans incidents incidents
and policies

Describe partners Engages partners to


EMR 2.05. Develops new partnerships to
and their Interacts with partners sustain relationships
Identification of ensure effective emergency
relationships with the on staff and ensure effective
key partners response
institution response

EMR 2.06. Describes emergency Updates agreements Trains staff on Negotiates agreements between
Execution of agreements between with partners to agreements in place to partner organizations to ensure

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agreements the institution and ensure emergency ensure emergency emergency response capability
other partners response capability response capability

Describes the plans, Develops the Oversees the collaboration with


EMR 2.07. Explains how the policies and organizational plans, emergency preparedness and
Emergency laboratory interacts procedures the policies and response networks to develop and
preparedness and with emergency institution has in place procedures to prepare implement plans, policies, and
response preparedness and to prepare for and for and respond to a procedures to prepare for and
networks† response networks respond to a public public health respond to a public health
health emergency emergency emergency

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

Subcompetency Beginner Competent Proficient Expert

Participates in
Facilitates the briefing
EMR 3.01. meetings and
Prepares information of key stakeholders to Manages implementation of COOP
Situational conference calls to
on the situation create situational measures and ICS activation
briefing receive information†
awareness
on the situation

Confirms staff are


Performs position Produces information Establishes organization's ICS
EMR 3.02. ICS available with proper
responsibilities as and documentation for structure, reporting procedures,
activation qualifications and
assigned briefings and chain of command
capabilities

EMR 3.03. Locates emergency Uses emergency


Instructs staff during Manages emergency evacuation
Emergency evacuation routes and evacuation routes and
evacuation and assembly
evacuation assembly areas assembly areas

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

Complies with Instructs staff on


EMR 3.04. Recognizes hazardous procedures for proper response to
Manages response to hazardous
Hazardous spill† spills or potential responding to hazardous hazardous spills or
spills or potential exposures
response exposures spills or potential potential
exposures exposures

Instructs staff on
Complies with policies, processes,
Describes emergency Manages emergency
EMR 3.05. emergency and procedures for
decontamination and decontamination and exposure
Emergency decontamination and emergency
exposure prevention† prevention policies, processes,
decontamination† exposure prevention decontamination
policies and procedures and procedures
policies and procedures and exposure
prevention

Adjusts workflow§ to
Identifies creative Implements a management
Describes circumstances ensure timeliness of
EMR 3.06. Surge strategies to system that promotes flexibility
for, and varying degrees diagnostic testing in
capacity manage surge or and maximizes the ability to
of surge collaboration with surge
overflow testing deliver surge capacity
partners

EMR 3.07. Describes the emergency Complies with the Ensures rapid and Manages the emergency
Emergency communication plan and emergency secure communication plan and the
communication the policies and communication plan and communications policies, processes, and
plan† procedures for receiving the policies and with emergency procedures for securely receiving
and disseminating procedures for receiving response partners and disseminating information

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information with and disseminating and/or public with emergency response


emergency response information with during partners and the public during
partners and/or public emergency response emergencies and emergencies and surge incidents
partners and/or public surge incidents

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

Subcompetency Beginner Competent Proficient Expert

Determines
whether staff and
Follows established Implements plans to
facilities are able
EMR 4.01. Short- plans to resume normal resume normal Manages re-opening and/or
to return to
term recovery operations after an operations after an continuation of routine services
normal operations
emergency event emergency event
after an emergency
event

EMR 4.02. After Assists with


Describes the AAR Participates in AAR
Action Review developing the Oversees the AAR process
process process
(AAR)† final AAR

Implements Develops recommendations to


Identifies improvements
Lists improvements to improvements to improve laboratory plans and
EMR 4.03. Long- to laboratory plans and
laboratory plans based laboratory plans operations based on the AAR
term recovery operations based on the
on the AAR and operations along with internal and external
AAR
based on the AAR partners and stakeholders

Determines
financial and staff
Verifies financial and staff
EMR 4.04. Lists costs relative to Explains costs relative to resources required
resources are in place to facilitate
Financial response and recovery response and recovery to facilitate
laboratory's response and
considerations activities activities laboratory's
recovery
response and
recovery

Assesses staff
compliance with
Describes legal and Implements legal and legal and Oversees staff compliance with
EMR 4.05. Legal
regulatory requirements regulatory requirements regulatory legal and regulatory requirements
and regulatory
for managing emergency for managing emergency requirements related to the managing of
issues
events events related to the emergency events
managing of
emergency events

* The process of identifying risks to organizational assets (including staff) and operations (including mission, functions,
image, and reputation); includes threat and vulnerability analyses and is the fundamental tool to help select the right risk
mitigation measures (e.g., engineered controls, standard policies and procedures) to achieve an acceptable level of security.
† This term is defined in Appendix B.
§ Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured
in the report of results, including pre-examination, examination, and postexamination procedures.

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

WFT 1.00. Content: gathers training content

Subcompetency Beginner Competent Proficient Expert

Supports needs
WFT 1.01. Needs Conducts needs Develops needs Prioritizes training needs based on
assessment
assessment* assessments assessment tools needs assessments
activities

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WFT 1.02. Adult Explains adult Selects principles and Integrates principles Ensures that adult learning
learning learning methodologies which of adult learning for principles are applied in designing
methodologies methodologies underpin adult use in designing training
learning training

Employs subject Implements Collaborates with national and


Develops emerging
WFT 1.03. Subject matter knowledge established science international scientific
science and
matter expertise in order to train and technology communities to create new
technology content
entry-level staff content knowledge on subject matters

Researches Implements training Designs training for Identifies emerging training topics
WFT 1.04. Training
emerging training for emerging training emerging training with national and international
topics
topics topics topics scientific communities

WFT 1.05.
Explains Develops new
Incorporation of Collaborates with
requirements* for processes* to capture Identifies emerging processes to
subject matter subject matter experts
the use of subject subject matter capture subject matter expertise
expertise into training to gather content
matter experts expertise
activities

WFT 2.00. Training design: designs training

Subcompetency Beginner Competent Proficient Expert

Recognizes the Applies instructional Evaluates instructional design and


Explains
WFT 2.01. instructional design design principles to training modalities* throughout
instructional design
Instructional design* principles in existing develop a new the entire menu of training for the
principles
training activities training activity organization

Explains learning Develops training


Creates learning Evaluates whether learning
WFT 2.02. Learning objective concepts activities around
objectives for new objectives were written following
objectives and training existing learning
training activities industry guidelines
activities objectives

Identifies different
WFT 2.03. Training Implements the Selects the modality Provides vision and guidance for
types of training
modalities modality for training for the training training modalities
modalities

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

WFT 2.00. Training design: designs training

Subcompetency Beginner Competent Proficient Expert

Explains cultural Ensures


Applies cultural
WFT 2.04. awareness and its Evaluates the incorporation of incorporation of
awareness principles
Cultural importance as it relates to cultural awareness principles cultural awareness
when designing
awareness developing training into training activities principles into
training activities
activities training activities

Incorporates
WFT 2.05. Develops instructional materials
Prepares instructional industry-wide
Instructional Assembles instructional for new programs that are
materials for existing instructional
materials materials aligned with the type of training
programs materials into the
preparation activity and modality
training program

Integrates multiple
WFT 2.06. Uses pre-existing training Evaluates training
types of training Develops training materials
Training materials materials to design materials from
materials into training from industry resources
application simple training industry resources
design

WFT 2.07. Delivers exercises within Integrates individual Evaluates training exercises Designs integrated
Training exercises a training session training lessons, training exercises
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including experiential with partners


exercises

Evaluates
WFT 2.08.
Explains formative Employs formative effectiveness of
Formative Creates formative assessments
assessment assessments formative
assessment*
assessments

Explains the Follows continuing


WFT 2.09. Selects continuing education Oversees the
requirements of the education provider
Continuing provider for new learning continuing education
continuing education requirements when
education activities provider process
provider conducting training

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

Subcompetency Beginner Competent Proficient Expert

WFT 3.01.
Ensures that equipment Oversees processes
Equipment Operates equipment Troubleshoots
capability aligns with the for upgrading training
preparation for needed to deliver training training equipment
training requirements equipment
training delivery

Creates supporting Develops storyboards for new Ensures that


WFT 3.02.
Tests eLearning courses materials or content courses using subject matter eLearning delivery
eLearning*
for storyboards expert materials systems are available

WFT 3.03. Provides support for Manages processes of Oversees the


Develops processes to manage
Learning learning environment the learning processes for the
the learning environment
environment* processes environment learning environment

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

Subcompetency Beginner Competent Proficient Expert

WFT 4.01. Explains presentation Differentiates


Develops presentation materials Creates strategies to
Learning materials for different presentation materials
to address learning preferences address learning
preferences and learning preferences and to address learning
and styles preferences and styles
styles styles preferences and styles

WFT 4.02. Explains the most Uses the most Ensures implementation of the
Oversees presentation
Presentation effective presentation effective presentation most effective presentation tools
engagement strategies
engagement tools and techniques tools and techniques and techniques

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

Carries out the


WFT 5.01.
Lists the steps the evaluation steps for Develops training Oversees the evaluation
Training
organization undertakes for standard training evaluation tools* for a of the training process
evaluation
training program evaluation evaluations for routine new activity for the organization
process*
courses

Contributes to development Implements the training Creates a training Evaluates the training
WFT 5.02.
of a training assessment assessment rubric to assessment rubric to assessment rubric to
Delivery of the
rubric* to ensure training ensure training ensure training ensure training outcomes
evaluation
outcomes are met outcomes are met outcomes are met are met

WFT 5.03. Gathers data as directed for Compiles tracking data Develops summative Interprets summative
Training reports* summative training reports into summative training training reporting tools data from reports for
reports delivery to stakeholders
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Recommends Implements
WFT 5.04. Shares training activity Assesses participants' improvements based on improvements to the
Training activity observations with achievement of training evaluation data from professional
effectiveness supervisor objectives training assessment development activities of
tools the laboratory

WFT 5.05. Identifies activities Facilitates activities


Develops a training
Continuous leading to the leading to the
Participates in continuous program improvement
improvement of continuous continuous
improvement activities plan based on program
the training improvement of a improvement of a
evaluation
program training plan training plan

WFT 6.00. Marketing: markets training opportunities

Subcompetency Beginner Competent Proficient Expert

Develops organizational
WFT 6.01. Participates in the Composes content for Manages the training
marketing plan for
Marketing marketing of training marketing materials marketing plan
training

* This term is defined in Appendix B.

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

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

Subcompetency Beginner Competent Proficient Expert

Applies basic scientific Oversees that laboratory


GEN 1.01. General Instructs others in
and laboratory concepts Ensures that accepted practices are in
scientific and concepts and theories
and theories* related to concepts and theories are accordance with
laboratory related to the specific
the specific testing that applied to laboratory accepted scientific and
concepts and testing that is conducted
is conducted in work testing laboratory concepts and
theories in work area
area theories

Oversees the policies,*


GEN 1.02. Instructs others in
Applies fundamental Ensures appropriate processes,* and
Mathematical and fundamental
mathematical and utilization of mathematical procedures* regarding
statistical mathematical and
statistical concepts and and statistical concepts the use of mathematical
concepts and statistical concepts and
practices in work area and practices and statistical concepts
practices practices
and practices

GEN 1.03. Critiques scientific and


Reads scientific and Discusses scientific and Integrates scientific and
Scientific and technological advances
technical literature technical advances technical advances into
technological to evaluate possible
relevant to own work relevant to own work laboratory operations
advances impact for the laboratory

Integrates basic laboratory Ensures that staff are


Applies basic laboratory Oversees the application
GEN 1.04. techniques into standard properly trained in the
techniques to laboratory of technical skills to
Technical skills operating procedures* and performance of technical
testing laboratory practices
new laboratory practices skills

Resolves routine technical Resolves complex


Oversees the policies,
Identifies routine problems with methods, technical problems with
processes, and
GEN 1.05. problems related to procedures, and methods, procedures, and
procedures related to
Troubleshooting technical duties and laboratory equipment,* laboratory equipment,
troubleshooting
responsibilities including documenting including documenting
technical problems
corrective action corrective action

GEN 1.06. Model Applies knowledge of Instructs others in model Implements model Manages policies,
laboratory model laboratory laboratory practices laboratory practices processes, and

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practices* practices procedures to ensure


staff comply with model
laboratory practices

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

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

Subcompetency Beginner Competent Proficient Expert

Oversees the policies, processes,


Documents actions Instructs others in use Ensures utilization of
and procedures for the creation
GEN 1.07. and results using of paper or electronic established paper and
and use of paper and electronic
Documentation established paper or methods or systems electronic documentation
methods or systems for
electronic systems for documentation methods or systems
documentation

Ensures that the use of Oversees the policies, processes,


GEN 1.08. Acts as a good Identifies methods to
public funds and and procedures to ensure the
Stewardship of steward of public improve stewardship
resources meet the environment supports effective
resources funds and resources of resources
policies for stewardship stewardship of resources

Serves as a role model,


Ensures staff compliance
Applies scientific consistently Oversees the policies, processes,
with the policies and
GEN 1.09. ethics and rules of conforming to the and procedures related to
procedures related to
Scientific ethics* conduct to the highest scientific scientific ethics and rules of
scientific ethics and rules
workplace standards and conduct
of conduct
practices

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

Adheres to policies, Ensures staff compliance


GEN 2.01. Use
processes, and Instructs staff in use with policies, processes,
and storage of Oversees the use and storage of
procedures for use and storage of and procedures for use
reagents and reagents and supplies
and storage of reagents and supplies and storage of reagents
supplies
reagents and supplies and supplies

Adheres to policies, Ensures staff compliance


GEN 2.02. Oversees the policies, processes,
processes, and Instructs staff in with policies, processes,
Reagent and procedures for reagent
procedures for preparing reagents and procedures for
preparation preparation
preparing reagents reagent preparation

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

Subcompetency Beginner Competent Proficient Expert

Adheres to policies, Ensures staff compliance


Oversees the policies, processes,
GEN 3.01. processes, and Instructs staff in the with policies, processes,
and procedures for the
Equipment procedures for operation of and procedures for the
operation of laboratory
operation operating laboratory laboratory equipment operation of laboratory
equipment
equipment equipment

Oversees the policies, processes,


GEN 3.02. Performs routine Instructs staff in Determines need for and procedures for the
Equipment system checks and procedures to ensure repair or replacement of maintenance, repair, and
maintenance maintenance equipment function laboratory equipment replacement of laboratory
equipment

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GEN 3.03. Performs calibration Performs calibration Develops processes and Oversees the policies, processes,
Instrument and of routine of complex procedures for calibration and procedures for calibration of
equipment instruments and instruments and of instruments and instruments and equipment
calibration equipment equipment equipment

GEN 3.04.
Inspects preventive
Preventive Documents Evaluates the preventive Oversees the preventive
maintenance and
maintenance and maintenance and maintenance and maintenance and calibration
calibrations records
calibration calibration activities calibration records program
for completeness
records*

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

Follows policies,
Instructs others in Monitors staff compliance
processes, and Oversees sample
GEN 4.01. Sample policies, processes, and with established sample
procedures for the management policies,
management* procedures for sample management policies,
management of processes, and procedures
management processes, and procedures
samples*

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

Subcompetency Beginner Competent Proficient Expert

Ensures staff compliance


Oversees the policies,
GEN 5.01. Sample Performs sample Instructs staff in sample with policies, processes,
processes, and procedures
analyses analyses analyses and procedures for sample
related to sample analyses
analyses

Adheres to policies, Instructs staff in policies, Oversees the policies,


Ensures staff compliance in
GEN 5.02.Testing processes, and processes, and processes and procedures
following established
workflow† procedures for testing procedures regarding that optimize and improve
testing workflow
workflow testing workflow testing workflow

Oversees the policies,


GEN 5.03. Quality Examines QC data over
Interprets QC data prior processes, and procedures
control (QC)* Performs QC activities time to establish QC ranges
to reporting results related to QC activities,
analysis and limits
including staff compliance

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

Subcompetency Beginner Competent Proficient Expert

Ensures staff compliance Oversees the policies,


Evaluates QC data for a
GEN 6.01. QC Assembles QC data for with established policies, processes, and procedures
given data reporting
evaluation evaluation processes, and procedures related to QC evaluation
period
for QC evaluation activities activities

Oversees the policies,


GEN 6.02. Test
processes, procedures,
analysis and Assembles test data for Interprets complex or
Analyzes test data and algorithms related to
results review and action ambiguous results
data analysis and results
interpretation
interpretation

GEN 6.03. Results Adheres to policies, Instructs staff in the Ensures staff compliance Oversees the policies,
reporting and processes, and policies, processes, and with policies, processes, processes, and procedures
data release procedures related to procedures related to and procedures related to related to reporting and
reporting and release of reporting and release of reporting and release of release of examination

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examination results examination results and examination results and results and notifiable
and notifiable results* notifiable results notifiable results results to partners

Performs laboratory
GEN 6.04. Oversees the policies,
testing and reporting Monitors TAT Identifies process
Turnaround time processes, and procedures
within specified or performance efficiencies to improve TAT
(TAT) related to TAT
expected TAT

Collects data for Oversees the policies,


GEN 6.05. Quality Explains the differences Evaluates QA indicator
reporting on QA processes, and procedures
assurance (QA)* between QA and QC data
indicators and processes related to QA

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

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

Subcompetency Beginner Competent Proficient Expert

Ensures staff
Complies with Instructs staff on
compliance with Oversees the policies, processes, and
GEN 7.01. regulatory regulatory
regulatory procedures regarding regulatory
Regulatory requirements* and requirements and
requirements and requirements and guidelines related
compliance guidelines related to guidelines related to
guidelines related to to laboratory testing
laboratory testing laboratory testing
laboratory testing

GEN 7.02. Monitors to ensure the


Proficiency Performs PT and Reviews PT and PT and alternative Oversees the policies, processes, and
testing* (PT) and alternative alternative assessment program procedures related to PT and
alternative assessment assessment results meets regulatory alternative assessments
assessment* requirements

GEN 7.03.
Ensures staff
Proficiency testing Reviews
Reports PT and compliance with Oversees the policies, processes, and
(PT) and submissions of PT
alternative reporting of PT and procedures related to PT and
alternative and alternative
assessment alternative assessment alternative assessment reporting
assessment assessment results
results
reporting

GEN 7.04. Participates in


Compiles results of Evaluates method Oversees the policies, processes, and
Method performance of
method validation validation and procedures related to method
validation* and method validation
and performance performance validation and performance
performance and performance
verification verification results verification
verification* verification

Complies with Instructs staff in Ensures staff Oversees that organizational policies,
GEN 7.05. policies, processes, policies, processes, compliance with processes, and procedures related to
Protected and procedures and procedures policies, processes, and protected information align with laws
information* regarding protected regarding protected procedures regarding and regulatory requirements and
information information protected information guidelines

* This term is defined in Appendix B.


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

TABLE 9. Public health laboratory competency guidelines: Safety domain

Safety subdomain: potential hazards

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

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Subcompetency Beginner Competent Proficient Expert

SPH 1.01. Physical Describes the physical Recognizes new physical Assesses staff knowledge of Evaluates the laboratory
hazards* in the hazards in the hazards in the the physical hazards in the facility for physical
laboratory facility laboratory facility laboratory facility laboratory facility hazards

SPH 1.02. Control Describes control Implements control Ensures staff knowledge of Establishes the control
measures* to be measures to be used measures to be used control measures to be used measures to be used
used when when physical hazards when physical hazards when physical hazards are when physical hazards
physical hazards are present in the are present in the present in the laboratory are present in the
are present laboratory facility laboratory facility facility laboratory facility

SPH 1.03. Work Describes work Implements work Ensures that staff implement Establishes the work
practices* to be practices to be used practices to be used the established work practices to be used when
used when when physical hazards when physical hazards practices when physical physical hazards are
physical hazards are present in the are present in the hazards are present in the present in the laboratory
are present laboratory facility laboratory facility laboratory facility facility

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

Safety subdomain: potential hazards

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

Subcompetency Beginner Competent Proficient Expert

SPH 2.01. Distinguishes biohazardous Manages the inventory of Establishes the policies,*
Lists the biological
Biological materials* from biological materials to processes,* and procedures*
materials in the
materials used in nonbiohazardous materials ensure it is complete and for implementing a biological
laboratory
the laboratory in the laboratory updated materials inventory system

SPH 2.02.
Describes hazards Assesses staff knowledge Ensures that staff are skilled
Hazards Recognizes hazards
associated with the of the hazards associated in describing and recognizing
associated with associated with new
biological with biological materials hazards associated with the
the biological biological materials used in
materials handled used in laboratory biological materials used in
materials handled laboratory procedures
in the laboratory procedures the laboratory
in the laboratory

SPH 2.03. Control Describes the


Ensures that staff
measures to be control measures Implements the control Establishes the control
implement the
used when to be used when measures to be used when measures to be used when
established control
working with working with working with biological working with biological
measures when working
biological biological materials materials
with biological materials
materials materials

SPH 2.04. Work Describes the work


Ensures that staff
practices to be practices to be Implements the work Establishes the work
implement the
used when used when practices to be used when practices to be used when
established work
working with working with working with biological working with biological
practices when working
biological biological materials materials
with biological materials
materials materials

SPH 2.05. Describes hazards Ensures that staff are capable


Trains staff in the hazards
Hazards associated with the Manages the hazards of recognizing, training, and
associated with the
associated with laboratory associated with managing the hazards
laboratory procedures
laboratory procedures laboratory procedures associated with laboratory
employed
procedures employed procedures

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

Subcompetency Beginner Competent Proficient Expert

SPH 3.01. Describes hazards Identifies hazards associated Assesses staff knowledge Ensures that staff are skilled
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Hazards associated with with the particular species of of the hazards associated in describing and recognizing
associated with working with animals used in the with the particular hazards associated with the
research animals research animals laboratory's research species of animals used research animals used in the
in the laboratory's laboratory's research
research

Describes possible Identifies the possible Assesses staff knowledge Evaluates possible route(s) of
SPH 3.02. Route
route(s) of route(s) of exposure to of the hazards associated exposure to infectious agents
of exposure* to
exposure to infectious agents in relation with the animal in relation to the animal
infectious agents
infectious agents to the animal procedures procedures used in the procedures used in the
in the animal care
in relation to used in the laboratory or laboratory or animal laboratory and animal
setting
animal procedures animal facility facility facilities

SPH 3.03. Control Describes control Ensures that staff


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

SPH 3.04. Work Describes work Ensures that staff


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

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

Safety subdomain: potential hazards

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

Subcompetency Beginner Competent Proficient Expert

Distinguishes
Establishes the policies,
SPH 4.01. hazardous chemicals* Manages the chemical
Identifies chemicals processes, and procedures
Chemicals used in from nonhazardous inventory to ensure it is
used in the laboratory for implementing a
the laboratory chemicals in the complete and updated
chemical inventory system
laboratory

SPH 4.02. Ensures that staff are


Describes hazards Recognizes hazards Assesses staff knowledge of
Hazards skilled in describing and
associated with associated with new the hazards associated with
associated with recognizing hazards
chemicals used in the chemicals used in the chemicals used in the
chemicals used in associated with chemicals
laboratory laboratory laboratory
the laboratory used in the laboratory

Describes control Implements Ensures that staff


SPH 4.03. Control
measures to be used established control implement the established Establishes the laboratory's
measures to be
when working with measures when control measures when Chemical Hygiene Plan,
used when
chemicals as working with working with chemicals in including specific control
working with
documented in the chemicals according to compliance with the measures to be used when
chemicals in the
laboratory's Chemical the laboratory's laboratory's Chemical working with chemicals
laboratory
Hygiene Plan* Chemical Hygiene Plan Hygiene Plan

Describes the work Implements Ensures that staff


SPH 4.04. Work
practices to be used established work implement established work Establishes the laboratory's
practices to be
when working with practices when practices when working Chemical Hygiene Plan,
used when
chemicals as working with with chemicals in including specific work
working with
documented in the chemicals according to compliance with the practices to be used when
chemicals in the
laboratory's Chemical the laboratory's laboratory's Chemical working with chemicals
laboratory
Hygiene Plan Chemical Hygiene Plan Hygiene Plan

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

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Subcompetency Beginner Competent Proficient Expert

Establishes the policies,


SPH 5.01. Describes the Manages the inventory of
Lists the radiological processes, and procedures
Radiological characteristics of the radiological materials to
materials used in the for implementing a
materials used in radiological materials ensure it is complete and
laboratory radiological materials
the laboratory used in the laboratory updated
inventory system

SPH 5.02. Ensures that staff are


Hazards Describes the hazards Recognizes hazards Assesses staff knowledge of skilled in describing and
associated with associated with associated with new the hazards associated with recognizing the hazards
the use of radiological materials radiological materials radiological materials used associated with radiological
radiological used in the laboratory used in the laboratory in the laboratory materials used in the
materials laboratory

Establishes, in
SPH 5.03. Control
Recognizes control Implements control Ensures that staff collaboration with
measures to be
measures to be used measures to be used implement established radiation safety staff, the
used when
when working with when working with control measures when control measures to be
working with
radiological materials radiological materials working with radiological used when working with
radiological
in the laboratory in the laboratory materials in the laboratory radiological materials in
materials
the laboratory

Establishes, in
SPH 5.04. Work
Describes work Implements work Ensures that staff collaboration with
practices to be
practices to be used practices to be used implement established work radiation safety staff, the
used when
when working with when working with practices when working work practices to be used
working with
radiological materials radiological materials with radiological materials when working with
radiological
in the laboratory in the laboratory in the laboratory radiological materials in
materials
the laboratory

Demonstrates
Evaluates use and
SPH 5.05. Describes monitoring operation and use of
Ensures the operation and suitability of monitoring
Radiation devices for the monitoring devices for
use by staff of radiation devices for the radiological
monitoring radiological materials the radiological
monitoring devices materials used in the
devices* used in the laboratory materials used in the
laboratory
laboratory

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

Safety subdomain: hazard control*

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

Subcompetency Beginner Competent Proficient Expert

Develops standard
Ensures the implementation
Employs engineering operating procedures
SHC 1.01. of policies, processes, and
Describes engineering controls to eliminate (SOPs)* and work
Engineering procedures related to
controls or reduce targeted instructions that
controls engineering control design,
laboratory hazards incorporate engineering
creation, and use
controls

SHC 1.02. Ensures that training is


Completes required
Training on Trains staff on Develops required training adequate and appropriate for
training before using
engineering engineering controls for engineering controls the engineering controls used
engineering controls
controls in the laboratory

SHC 1.03. Describes function Performs function Manages the procedures for Develops policies, processes,
Function verification, verification, function verification, and procedures to ensure
verification* and maintenance, and maintenance, and maintenance, and function verification,
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maintenance of troubleshooting troubleshooting troubleshooting for maintenance, and


engineering procedures for processes and engineering controls troubleshooting for
controls engineering controls procedures for engineering controls
engineering controls

Recognizes when Implements Manages processes and Develops policies, processes,


engineering controls procedures to address procedures for addressing and procedures for
SHC 1.04.
are compromised, and report when and reporting situations in remediation and reporting of
Malfunction of
malfunctioning, or engineering controls which engineering controls engineering control
engineering
nonfunctioning, and are compromised, are compromised, malfunctions to ensure
controls
the resulting reporting malfunctioning, or malfunctioning, or minimal exposure and release
requirements* nonfunctioning nonfunctioning 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

Develops processes and


Oversees the implementation
SHC 2.01. Good Describes good Practices good procedures related to the
of policies, processes, and
housekeeping housekeeping housekeeping establishment and
procedures related to good
procedures* procedures procedures maintenance of good
housekeeping
housekeeping

SHC 2.02. Complies with Ensures staff adherence to


Describes personal Develops personal hygiene
Personal hygiene personal hygiene personal hygiene policies,
hygiene procedures procedures
procedures* procedures processes, and procedures

SHC 2.03. Safety Describes proper work Uses proper work Ensures staff knowledge and
Develops proper work
practices and practices and practices and use of proper work practices
practices and procedures
procedures procedures procedures and procedures

Describes how Monitors staff Implements procedures to Designs processes and


adherence to own adherence to ensure scheduling of work procedures to ensure
SHC 2.04. Work
scheduled work established work activities and/or workers' scheduling of work activities
schedules
activities and tasks schedules and tasks minimize staff and/or workers' tasks
minimizes exposure assigned tasks exposure levels minimize staff exposure levels

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

Safety subdomain: hazard control*

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

Subcompetency Beginner Competent Proficient Expert

Describes appropriate Develops procedures Ensures staff knowledge of


SHC 3.01. PPE Selects appropriate
PPE and its limitations for the appropriate procedures for the appropriate
selection PPE for jobs assigned
for jobs assigned selection of PPE selection of PPE

Describes specific PPE


Uses specific PPE for Determines
SHC 3.02. PPE and its limitations for Ensures staff compliance with
each laboratory procedures for use of
use use with each procedures for use of specific PPE
procedure specific PPE
laboratory procedure

Describes pre-and Implements pre-and Develops pre-and Ensures staff knowledge of pre-
SHC 3.03. PPE
postinspection postinspection postinspection and postinspection procedures for
inspection
procedures for PPE procedures for PPE procedures for PPE 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

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Subcompetency Beginner Competent Proficient Expert

SHC 4.01. Hazard Describes the Implements Develops procedures Ensures staff compliance with
reporting, procedures for procedures for to report, track and reporting, tracking, and
tracking, and reporting hazardous reporting and investigate hazards in investigating hazards in the
investigation conditions tracking all hazards their workspace 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

Complies with Implements the


Develops the policies, processes,
SHC 5.01. Performs required processes and processes and
and procedures to ensure
Planned preventive maintenance procedures to ensure procedures to ensure
equipment continues to function
maintenance functions equipment continues equipment continues
effectively
to function effectively to function effectively

Describes
Develops the policies, processes,
troubleshooting Complies with Implements the
SHC 5.02. and procedures to ensure repairs
methods to determine processes and processes and
Corrective are conducted in accordance with
whether equipment is procedures to ensure procedures to ensure
maintenance organizational safety and health
malfunctioning and the equipment repairs equipment repairs
procedures
cause

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

Implements
SHC 6.01. Describes procedures Manages procedures Develops policies, processes, and
procedures for spill
Decontamination for spill cleanup and for spill cleanup and procedures for spill cleanup and
cleanup and
of laboratory decontamination of decontamination of decontamination of laboratory
decontamination of
waste laboratory waste laboratory waste waste
laboratory waste

Implements
SHC 6.02. Describes procedures Manages procedures Ensures staff compliance with
procedures for
Segregated waste for laboratory waste for laboratory waste laboratory waste categorization
laboratory waste
categorization* categorization and categorization and and handling policies, processes,
categorization and
and handling handling handling and procedures
handling

Implements
Describes procedures Manages procedures Ensures staff compliance with
SHC 6.03. procedures for
for disposal and for disposal and policies, processes, and
Treatment and disposal and
treatment of laboratory treatment of procedures for disposal and
disposal treatment of
waste laboratory waste treatment of laboratory waste
laboratory waste

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

Safety subdomain: hazard control*

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

Subcompetency Beginner Competent Proficient Expert

Ensures staff compliance


Describes procedures Implements procedures Manages procedures for
SHC 6.04. Waste with policies, processes, and
for laboratory waste for laboratory waste laboratory waste
reduction procedures for laboratory
reduction reduction reduction
waste reduction

SHC 6.05. Describes procedures Implements procedures Manages procedures for Ensures staff compliance
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Regulated waste* for preventing public for preventing public preventing public access with policies, processes, and
access access to regulated access to regulated waste to regulated waste procedures for preventing
waste public access to regulated
waste

Describes procedures Implements procedures Develops procedures to Ensures staff compliance


SHC 6.06. Waste for reporting and for reporting and ensure that issues or with policies, processes, and
management responding to issues or responding to issues or problems regarding procedures to address
issues and problems regarding problems regarding laboratory waste laboratory waste
problems laboratory waste laboratory waste management are reported management issues or
management management and addressed problems

Ensures staff compliance


Describes procedures Implements procedures
SHC 6.07. Develops procedures for with policies, processes, and
for monitoring the for monitoring the
Monitoring and monitoring the laboratory procedures for monitoring
laboratory waste laboratory waste
evaluation waste management plan the laboratory waste
management plan management plan
management plan

Safety subdomain: administrative controls*

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

Subcompetency Beginner Competent Proficient Expert

Ensures that comprehensive


Complies with the
Ensures staff compliance Implements the safety safety policies, processes,
SAC 1.01. Safety safety program
with safety program program and related and procedures are
program requirements for the
requirements training programs developed as part of the
jobs performed
safety program

Evaluates the safety


SAC 1.02. Participates in audits of Conducts audits of the Designs safety program
program audit results to
Program audits the safety program safety program audits
identify problem areas

Explains the
SAC 1.03. Safety Participates in safety Conducts safety Ensures staff compliance
importance of safety
inspections inspections inspections with safety inspections
inspections

SAC 1.04. Collects data relating to Prepares evaluation


Provides feedback on Designs evaluation reports
Program the effectiveness of the reports for the safety
the safety program for the safety program
evaluation safety program program

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

Subcompetency Beginner Competent Proficient Expert

Describes current Complies with current Ensures staff compliance


Instructs staff on current
SAC 2.01. regulatory regulatory requirements with current regulatory
regulatory requirements
Regulatory requirements and and guidelines requirements and guidelines
and guidelines governing
requirements and guidelines governing governing the safe governing the safe
the safe performance of
guidelines the safe performance of performance of performance of laboratory
laboratory procedures
laboratory procedures laboratory procedures procedures

SAC 2.02. Participates in a


Complies with Ensures staff compliance
Institutional Describes institutional leadership role on
institutional safety with institutional safety
safety safety committees institutional safety
committee requirements committee requirements
committees* committees

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
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eliminate them

Subcompetency Beginner Competent Proficient Expert

Oversees the policies, processes,


and procedures related to risk
Implements control
SAC 3.01. Risk Describes the risk Manages the risk assessment to ensure controls
measures identified in
assessment† assessment process assessment process are appropriate for activities,
risk assessments
agents and materials used in
laboratory

Conducts routine
Designs policies, processes, and
SAC 3.02. Reviews reports of monitoring of staff
Reports any incidents, procedures for reporting and
Incident* incidents to identify root compliance
including near-misses performing root-cause analyses
reporting causes and problems regarding incident
of incidents
reporting

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

Subcompetency Beginner Competent Proficient Expert

Monitors staff Designs the vaccination


SAC 4.01. Describes the Identifies staff eligible to
compliance with the program based on exposure
Vaccination organization's participate in the
vaccination risks and regulatory
program vaccination program vaccination program
program requirements

Monitors staff
Identifies staff eligible to Designs the medical surveillance
SAC 4.02. Medical Describes the compliance with the
participate in the program based on risks
surveillance organization's medical medical
medical surveillance encountered and regulatory
program* surveillance program surveillance
program requirements
program

Ensures staff Develops the exposure


SAC 4.03. compliance with monitoring policies and
Describes exposure Complies with exposure
Exposure exposure processes based on risks
monitoring procedures monitoring procedures
monitoring* monitoring policies encountered and regulatory
and processes requirements

Complies with
organizational
Identifies the process to Develops occupational incident
SAC 4.04. requirements and Prepares summary
obtain medical services response plan* including regular
Occupational healthcare provider of occupational
after an occupational review and revisions following
incidents treatment plans incidents
incident an occupational incident
pertaining to an
occupational incident

Safety subdomain: communication and training

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

Subcompetency Beginner Competent Proficient Expert

Describes safety signage Evaluates safety


and documentation as Adheres to information signage and
SCT 1.01. Safety Ensures staff compliance with
well as how signage is and directives in safety document
signage* safety signage and documents
used to convey signage and documents* placement and
information usage

SCT 1.02. Safety Describes a variety of Employs a variety of Implements a Ensures a variety of
communication communication tools and communication tools variety of communication tools and
tools techniques promoting and techniques communication techniques promoting work
the work practices promoting the work tools and practices are employed in their
practices employed in techniques for the area of responsibility
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employed in own area of own area of promotion of safe


responsibility responsibility work practices

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

Implements procedures
Adheres to to ensure staff Ensures staff compliance
SCT 1.03. Describes labeling of procedures for compliance with with regulatory
Labeling samples* and containers labeling of samples regulatory requirements requirements for labeling
and containers for labeling of samples of samples and containers
and containers

Explains signals and Ensures the


SCT 1.04. Signals Recognizes signals and Assesses staff knowledge
alarms in the implementation of all
and alarms alarms in areas assigned of signals and alarms
laboratory facility 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

Provides training on
the work practices
Assesses safety training Ensures development and
SCT 2.01. Safety Complies with requirements and techniques
needs and the impact of implementation of safety
training to obtain safety training required for staff to
safety training training for all staff
safely perform their
job duties

Develops policies,
Adheres to
SCT 2.02. Implements procedures processes, and procedures
Describes requirements for procedures for
Training for documenting staff for documentation and
documenting safety training recording safety
documentation safety training verification of staff
training 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

Adheres to
SDR 1.01. Safety Describes procedures for Manages safety Designs the safety
procedures for safety
document safety document document management document management
document
management management process system
management

Implements processes
Designs policies,
and procedures for
Ensures restricted or processes, and procedures
Identifies any restricted or maintaining
SDR 1.02. Safety confidential safety for document control and
confidential safety confidentiality* of
document access documents are not access that adhere to
documents internally and externally
disclosed regulatory and
derived safety
accreditation requirements
information

SDR 1.03. Describes responsibilities for Complies with Ensures staff compliance Designs policies,
Occupational documenting Occupational documentation with reporting of OSHA- processes, and procedures
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injuries and Safety and Health procedures for recordable occupational to ensure reporting for
illnesses Administration (OSHA)* OSHA-recordable injuries and illnesses OSHA-recordable
documentation recordable occupational occupational injuries occupational injuries and
injuries and illnesses and illnesses illnesses

Complies with
Describes responsibilities in established medical Implements processes Designs policies,
SDR 1.04. Medical
complying with established surveillance and procedures for processes, and procedures
surveillance
medical surveillance documentation and medical surveillance for medical surveillance
documentation
recordkeeping procedures recordkeeping documentation documentation
procedures

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

Describes the Implements procedures for Designs policies, processes, and


SDR 1.05. Adheres to
procedures for documentation and procedures for documentation
Exposure procedures for
documenting retention of exposure and retention of exposure
monitoring documenting
exposure monitoring information as monitoring information as
documentation exposure monitoring
monitoring required by regulations required by regulations

Complies with
SDR 1.06. Safety Describes safety Develops procedures for Designs policies, processes, and
procedures for safety
inspection inspection safety inspection procedures for safety inspection
inspection
documentation documentation documentation documentation
documentation

Describes Complies with


Ensures staff compliance with
procedures for procedures for Develops procedures for
SDR 1.07. policies, processes, and
documenting the documenting the documenting the handling
Hazardous waste procedures for documenting the
handling and handling and and transport of hazardous
documentation handling and transport of
transport of transport of waste
hazardous waste
hazardous waste hazardous waste

Designs policies, processes, and


Complies with Ensures staff compliance to
SDR 1.08. Safety procedures ensuring staff
recommendations recommendations and
reports to staff Reads safety reports compliance to recommendations
and mandates of mandates made in safety
members and mandates made in safety
safety reports reports
reports

* This term is defined in Appendix B.


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

TABLE 10. Public health laboratory competency guidelines: Surveillance domain

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

Subcompetency Beginner Competent Proficient Expert

SRV 1.01. Describes the Explains the Ensures selected laboratory Oversees the policies,* processes,*
Function of importance of integration of public testing and reporting and procedures that ensure
laboratory public health health laboratory procedures* are aligned with laboratory data will support public
surveillance laboratory testing into broader surveillance activities and health surveillance activity and
program requirements* program requirements
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surveillance surveillance
testing programs

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

Subcompetency Beginner Competent Proficient Expert

Describes Manages the approval and


Reports data to Contributes to determination of
SRV 2.01. notification communication of public
laboratory national, state, and local
Notification rules and health surveillance test
management notification conditions
regulations results

SRV 3.00. Surveillance testing: performs surveillance testing

Subcompetency Beginner Competent Proficient Expert

Describes test
Identifies the Directs development and
sample*
SRV 3.01. functional Creates surveillance testing modifications to surveillance
collection,
Surveillance requirements protocols that include testing systems based on
storage, and
testing systems of surveillance functional requirements jurisdictional guidance and
analytical
testing protocols† analytical capabilities
requirements

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

SRV 3.00. Surveillance testing: performs surveillance testing

Subcompetency Beginner Competent Proficient Expert

Describes test Employs established


Customizes testing workflow
SRV 3.02. sample collection, testing workflow and Directs development and
policies and procedures to
Surveillance storage, and test methods for the modifications to surveillance
the surveillance target
testing workflow§ analytical method surveillance target testing system workflows
requirements
workflows requirements

Participates in
performance Applies technical knowledge
SRV 3.03. Oversees the selection and
Tests samples for evaluation of to develop test methods and
Surveillance creation of public health
surveillance surveillance test testing capabilities used in
testing surveillance tests
methods and testing surveillance
capabilities

SRV 3.04. Describes at least Contributes to the


Informs supervisor of Reports potential outbreak
Outbreak* or one definition of an modification of outbreak or
potential outbreak or or exposure events to key
exposure event* outbreak or exposure event recognition
exposure event stakeholders
detection exposure event processes or definitions

SRV 3.05. Sample Ensures that outbreak Contributes to sample


Receives outbreak or Collaborates with key
collection for or exposure event collection guidelines for
exposure event stakeholders to determine
outbreak or samples meet sample outbreak or exposure event
samples for testing the best samples to collect
exposure events collection criteria scenarios

Follows sample
Ensures that outbreak
SRV 3.06. Testing prioritization Reports outbreak or Represents the laboratory in
or exposure event
for outbreak or schema for testing exposure event testing After Action Reviews* for
samples are prioritized
exposure events during an outbreak results to key stakeholders outbreak or exposure events
according to schema
or exposure event

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

Subcompetency Beginner Competent Proficient Expert

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SRV 4.01. Critical Describes critical Applies critical event Evaluates plans and After Modifies the policies,
event planning event response processes and Action Review findings processes, and procedures for
processes and procedures related to following critical events critical surveillance events
procedures related surveillance based on results of exercises
to surveillance or actual events

Describes own
critical event Manages resources Oversees the activation and
SRV 4.02. Critical Implements the critical
response duties required to respond to termination of the critical
event response event response plan
related to critical events event response plan
surveillance

Communicates testing Coordinates testing


SRV 4.03. Describes the need Ensures implementation of
priorities to staff and activities during critical
Coordination of to coordinate testing response plans during critical
laboratory events to align with
response priorities events
management identified testing priorities

Identifies when Develops plans to address Determines the overall


Applies technical
SRV 4.04. New current testing testing capabilities for a strategy for development of
knowledge to
testing capabilities do not specific new organism or new testing capabilities
implement new testing
capabilities exist to test an analyte during critical during critical surveillance
capabilities
analyte or organism surveillance events events

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

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

Subcompetency Beginner Competent Proficient Expert

Enters
Determines demographic
demographic Communicates the
SRV 5.01. Ensures submission of crucial information fields required in
information that is required demographic
Demographic demographic information by informatics systems,
necessary to carry information to
information submitters requisition forms, and
out surveillance submitters
reports
testing activities

Determines policies,
Enters sample
processes, and procedures for
information that is
SRV 5.02. Sample Monitors the capture of Ensures collection of sample sample information
necessary to carry
information sample information information collection based on
out surveillance
jurisdictional requirements
testing activities
and guidelines

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

Subcompetency Beginner Competent Proficient Expert

Develops standards for data


Describes
SRV 6.01. Data Analyses laboratory Interprets laboratory analysis and for
surveillance data
analysis surveillance data surveillance data interpretation of laboratory
analysis methods
surveillance data

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

Subcompetency Beginner Competent Proficient Expert

Determines validity and Coordinates modifications to


Ensures data collection
SRV 7.01. Data Conducts data reliability of data data collection systems using
system adheres to laboratory,
collection entry collection instruments state and national guidance
local, and national standards
and methods and methods

SRV 7.02. Data Uses secure and Ensures that the design Develops secure and stable Develops standards for
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storage and stable data storage of storage and retrieval data storage and retrieval secure and stable data
retrieval and retrieval databases include the systems, including creating storage and retrieval
systems necessary variables and new variables as necessary to
data dictionary support analysis of data

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

Subcompetency Beginner Competent Proficient Expert

Reports significant
Adheres to policies Develops plans with
SRV 8.01. results with Monitors significant results
and procedures to customers to identify
Significant values interpretation to to ensure staff compliance
verify significant significant results in the
and results laboratory management with policies for reporting
results population or environment
and customers*

Provides trend Explains trends in Evaluates testing capabilities


SRV 8.02. Trends results to Identifies trends in surveillance data to based on trend data to
in data laboratory surveillance data laboratory management and address customer needs and
management customers public health issues

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

SRV 9.00. Partnerships: maintains partnerships to conduct surveillance

Subcompetency Beginner Competent Proficient Expert

Communicates Implements the multi-


SRV 9.01. Manages the multi- Develops a multi-disciplinary
approved laboratory disciplinary
Multidisciplinary disciplinary surveillance surveillance communication
information to other surveillance
teamwork communication plan plan
institutions communication plan

Evaluates effectiveness
Guides partners in
SRV 9.02. and efficiency of
Explains sample selection of laboratory Develops surveillance policies,
Education and surveillance processes
requirements and methods, data processes, and procedures with
feedback for and procedures
testing procedures collection, and partners
partners between laboratory and
evaluation
partners

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

Subcompetency Beginner Competent Proficient Expert

Describes importance Reports surveillance Synthesizes surveillance and


SRV 10.01. and use of oral and and monitoring data Explains surveillance monitoring data orally and in
Presentation of written communication orally or in writing to and monitoring data writing for national and
surveillance and in presenting laboratory orally or in writing to international audiences for
monitoring data surveillance and management and external stakeholders policy decision-making
monitoring data epidemiologists purposes

* This term is defined in Appendix B.


† A detailed plan for conducting a scientific procedure.
§ Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured
in the report of results, including pre-examination, examination, and postexamination procedures.

TABLE 11. Public health laboratory competency guidelines: Informatics domain

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

Subcompetency Beginner Competent Proficient Expert

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INF 1.01. Sample Describes electronic Verifies electronic Evaluates the electronic Designs log-in screens to
receiving and modules* used to log accessioning activities modules needed for sample automate sample receiving and
accessioning in samples with to ensure completeness receiving and accessioning accessioning and to automate
corresponding and accuracy processing of electronic test
electronic requests request messages

Describes electronic Performs oversight of Manages daily electronic


INF 1.02.
modules used to entered data to ensure data exchange activities
Electronic data Designs systems to automate
receive data on accurate mapping of regarding test requests to
exchange electronic test orders and work
samples using one client data to ensure efficient operations
regarding test processes*
or more standard comparable fields in and resolution of root
requests
message types* electronic systems causes of errors

Develops codes for generation


Evaluates use of vocabulary of messages using multiple
INF 1.03. Manages use of
Lists local codes and standards for identification standardized vocabulary
Vocabulary vocabulary standards
standardized codes of missing or misidentified formats and integration of
standards* across parties
codes local and new codes and
vocabulary standards

Verifies the electronic Designs workflows† and


Describes processes Evaluates the need for new
INF 1.04. Test assignment of tests to modules to automate
and procedures* for test orders and associated
orders specific laboratory assignment of test orders to
test orders meta data
programs* specific laboratory programs

INF 1.05.
Troubleshoots
Hardware to Uses basic Configures a variety of Integrates use of new
installation and
promote sample hardware, scanners, complex hardware to technologies for sample
operation of basic
handling and robotics ensure proper operation accessioning
automation hardware
efficiency

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

Designs modules to
Manages problem automate the entry of
Describes required Verifies the routine entry of resolution auxiliary data, the
INF 1.06. Capture
identifiers and core metadata and pass-through concerning entry of identification of core data
of auxiliary data
data elements auxiliary data metadata and elements, and the
auxiliary data 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

Describes use of
Designs systems to
predefined electronic
Verifies the assignment of Manages automate the electronic
INF 2.01. Test modules to assign
samples to individual test prioritization for management of pre-
preparation and samples or batches*
processes or test processing preparation and examination* operations
receipt of samples of samples to
combinations handling of samples on samples received
processes in the
individually or in batch
laboratory

INF 2.02. Describes how to use Verifies the receipt of samples Ensures that valid Designs systems to
Electronic test electronic modules to and associated electronic test values and test automate the electronic

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requests from manage individual or requests from submitters codes are properly management of test
submitters batches of samples harmonized requests from submitters
from submitters between submitters
and receiving
laboratory

Describes how to use


INF 2.03. LIMS Evaluates the LIMS Designs systems to
electronic modules to
tracking of testing Verifies effectiveness of ongoing tracking of testing automate and manage the
track testing
processes and sample source tracking and processes and tracking of testing
processes and
associated sample submitter's monitoring efforts associated sample processes and associated
associated sample
sources sources sample sources
sources

Designs analytical
Describes electronic Troubleshoots sequences for instrument
INF 2.04. Test modules, vocabulary, Populates test results data using automated test integration and data
results recording and usage for specific pre-existing modules results data capture capture utilities to
test results utilities automate data transfer
from instruments

Describes
Evaluates the need
preparation of data Develops workflows and
INF 2.05. Data Verifies data and results using for new tracking
summaries that are utilities to ensure that
review predefined progress reports reports to facilitate
used for review needed data are supplied
data review
processes

Verifies that the electronic Institutes rules to Designs the processes for
transfer of quality assurance ensure that automating data
Explains test result (QA)* and quality control (QC)* laboratory programs verification and
INF 2.06. Data
choices that exist for data* occurs to ensure that test have tools to associating QA and QC
verification
specific test requests results meet procedural manage data data with individual
requirements* and auto- verification sample tests and batches
assignment processes before reporting

Describes the Develops code for design


INF 2.07. Auto- Evaluates the
electronic processes Verifies that auto-assignment of and configuration of
assignment of processes for auto-
that define auto- reflex or repeat testing is processes for automating
reflex* or repeat assignment of reflex
assignment of reflex performed the assignment of reflex or
testing or repeat testing
or repeat testing repeat testing

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

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

Subcompetency Beginner Competent Proficient Expert

Describes electronic
Appraises solutions for
INF 3.01. modules used to
Verifies analytical data, data selection for Constructs queries for ad hoc
Processing of data print data and
information, and reports nonroutine reports and data searches
for reports information* in
for research purposes
automated reports

Describes use of
Selects results for
electronic modules to
INF 3.02. Report reporting using Evaluates report Develops code to query and
generate automated
production standardized predefined production processes report laboratory data
and manual reports
report formats
or test results

INF 3.03. Sends predefined Reports test results using Manages the tracking Develops reports that contain
Electronic reports via electronic predefined electronic and needs assessment* electronic messages for test
reporting reporting formats messages that meet of electronic reporting results using agreed-upon
agreed-upon standards of data
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standards and vocabulary for


message creation and transport

Verifies that reports


adhere to submitters' data Modifies noncomplex
INF 3.04. Prints predefined
exchange format electronic formats to Develops automated processes
Management of reports according to
requirements for meet customer* to manage reporting of results
reports policies*
electronic results requirements
submittal and reporting

INF 4.00. Laboratory test scheduling: manages laboratory test scheduling

Subcompetency Beginner Competent Proficient Expert

Prints existing
INF 4.01. worksheets, work Prioritizes test scheduling Develops work lists, Develops processes for
Scheduling lists, and test to resolve conflicts and worksheets, and test integration of documents to
documents* scheduling turnaround time scheduling documents link test orders with test results
documents

Enters data to Uses specific data Evaluates the workflow


INF 4.02. Develops codes to automate the
remove or restore elements associated with for process
Management of creation of test status reports
completed test process improvement to improvement
test schedules and workflows
requests manage test schedules opportunities

Organizes specific data


Logs in samples elements associated
INF 4.03. Manages test requests Develops systems to
according to with process
Prioritization of using laboratory-specified electronically generate a real-
predefined generic improvement
tests criteria time test schedule
priorities indicators* to prioritize
test scheduling

INF 5.00. Prescheduled testing: manages prescheduled testing

Subcompetency Beginner Competent Proficient Expert

Describes electronic
Troubleshoots Develop automated processes
modules for receipt
Manages scheduling of electronic systems to to manage the receipt and
INF 5.01. and processing of
single or recurring test preschedule tests and processing of pre-scheduled
Prescheduling pre-scheduled
requests to predict and adjust samples, recurring test
samples and kit
workload requests, and kit distribution
distribution

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

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

Subcompetency Beginner Competent Proficient Expert

Evaluates
automated
Uses predefined electronic
INF 6.01. modules that Develops systems to
modules to enter data relevant to Assigns identifiers to
Tracking samples verify system determine sample tracking
track all steps in the sample samples
at accessioning operations and location
lifecycle*
regarding
tracking

INF 6.02. Chain Uses predefined modules to track Ensures staff compliance Manages Develops systems to
of custody and document custody of the with chain of custody electronic electronically automate the
sample from receipt to disposal or policies and procedures tracking data by communication of chain of
return to submitter validating that custody data tracking to
chain of users and submitters
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custody is
complete and
documented

Verifies that predefined


Uses predefined modules to link
modules allow creation,
demographic data with data on Evaluates
tracking, and Develops systems to
INF 6.03. Chain chain of custody, sample existing and
maintenance of sample integrate data elements into
of custody data appropriateness,* sample future modules
and aliquot hierarchy automated chain of custody
elements handling, and elements of sample for tracking
through the LIMS management
analyst location, time, and data elements
throughout the
defined storage parameters
laboratory

Creates work Develops modules to


lists, incorporate factors that
INF 6.04. Uses predefined modules to track Verifies the routine worksheets, affect automated
Tracking samples samples assigned to laboratory tracking of aliquots, and assignment of samples to
in analytical programs during analytical instrument sequence workgroups to work lists and integration of
processes processes numbers, and work lists improve the sample tracking into
tracking of routine laboratory
samples functions

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

Subcompetency Beginner Competent Proficient Expert

Determines the
availability and
Verifies the tracking, cost- Designs code or scripts to
Applies predeveloped electronic
INF 7.01. Supplies management, and effectiveness of automate activities to track,
modules to order supplies and
tracking maintenance of in-house order, and manage
control inventory
inventory manufacturing inventory
and use of
supplies

Evaluates data
to improve the
INF 7.02. Performs data entry into existing
Validates the production current and Writes code or scripts to
Inventory electronic modules to document
of inventory future states of automate inventory control
production production of inventory
inventory
production

Validates
INF 7.03. Maintains the database Develops workflows for
Accesses manufacturing manufacturing
Manufacturing of manufacturing manufacturing
formulations electronically formulations
formulations formulations formulations
and SOPs

Verifies the use of codes


INF 7.04. Supply and parameters Manages order Develops workflows to
Enters inventory order data into
orders and necessary to automate frequency and automate the ordering of
electronic order systems
vendors electronic orders of timetables supplies from vendors
supplies

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. Explains data Identifies analytical data and Develops automated Configures modules to

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Laboratory data elements and results and the exchange of interfaces to export automate the export of
collection formats necessary this information using data from instruments analytical data to electronic
for data collection predefined modules to electronic storage storage
and exchange

Describes use of
Maps electronic data to form
predefined modules
INF 8.02. Performs predefined queries Develops ad hoc messages consistent with
to deliver
Electronic of analytical data for queries for electronic client message structure,
predefined
messaging electronic messaging messaging format, and vocabulary for
messages to
export
partners

Describes Sends automated electronic


INF 8.03.
predefined results to partners according Determines secure Ensures the use of secure
Electronic
electronic to established electronic electronic messaging electronic messaging
messaging
messaging transport messaging transport transport protocols transport protocols
transport
protocols§ protocols

Describes Verifies local codes are pre- Evaluates processes Automates the mapping of
INF 8.04.
vocabulary mapped to nationally that automate the test codes and results to all
Message
necessary for data accepted standard codes for linking of local and standardized notifiable
vocabulary
exchange test requests and test results national codes diseases and conditions

Manages the
Describes standard Communicates test orders Develops protocols for
INF 8.05. Test automation of test
test order with partners using automated electronic test
order creation orders in collaboration
vocabulary predefined modules order creation
with partners

Manages the
Describes standard automation of test
INF 8.06. Test Processes test orders Develops protocols for
test order receipt order receipts and
order receipt and received from partners using electronic test order receipts
and notification notification in
notification predefined modules and notification
vocabulary collaboration with
partners

Manages the
Describes standard Communicates test results automation of test Develops protocols for
INF 8.07. Test
test results with partners using results reporting in electronic test order results
results reporting
vocabulary predefined modules collaboration with reporting
partners

Manages the
INF 8.08. Test Describes test Verifies test results receipt automation of test
Develops protocols for
results results receipt with partners using results receipts in
electronic test results receipts
acknowledgment acknowledgment predefined modules collaboration with
partners

Manages the workflow and


INF 8.09. Performs routine data Troubleshoots operation of exchange
Describes exchange
Exchange exchange using predefined exchange network networks according to
networks
networks modules interfacing information exchange
standards

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

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

Subcompetency Beginner Competent Proficient Expert

INF 9.01. Meta Enters meta data Verifies the collection Ensures the ability to Develops modules and
data and and demographic and editing of meta data capture, retrieve, and link workflows to electronically

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demographic data data associated and demographic data meta data and capture, retrieve, and link meta
with laboratory using predefined demographic data data and demographic data
testing modules associated with associated with laboratory
laboratory testing testing

Explains how Writes code or procedure code


Performs predefined Develops ad hoc queries
automated for third-party software to
queries on collected data to collect extracts of data
statistical automate the querying and
INF 9.02. for predefined statistical for unique statistical
evaluation tools reporting of statistical data to
Statistical analysis analyses to link meta data analyses to link meta data
link meta data and link meta data and
and demographic data and demographic data
demographic data demographic data within
within reports within reports
within reports reports

Describes the Provides reporting and


INF 9.03. Develops ad hoc Develops workflows and
production of evaluation of laboratory
Laboratory statistical analyses to automation tools to ensure the
laboratory program performance
performance evaluate key performance implementation of laboratory
performance data using predefined
analyses indicators performance-based analyses
reports reports

Evaluates the availability Develops modules for LIMS-


Describes modules Uses predefined tools to
of validated tools to associated or third-party
for entering integrate GIS data with
INF 9.04. Spatial integrate GIS data with software to integrate GIS data
geographic laboratory testing results
data laboratory testing results with laboratory testing results
information system and with meta and
and with meta and and with meta and
(GIS) data demographic data
demographic data demographic data

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

Subcompetency Beginner Competent Proficient Expert

Links existing
billing code(s) with Evaluates the automated
Troubleshoots billing Develops workflows and
INF 10.01. Billing associated capability to link billing
data associated with modules to manage the
data laboratory services data with laboratory
laboratory services collection of financial data
at time of services
accessioning

Performs advanced Develops workflows and


functions of automated Manages accounts modules to automate the
INF 10.02. Enters billing data
electronic billing and receivable systems integration of billing
Accounts in an accounts
linking of laboratory regarding billing of information with accounts
receivable* receivable program
services to accounts services rendered receivable software and
receivable systems financial services

Verifies that correct


Identifies Develops workflows and
INF 10.03. Cost of accounting codes are
accounting codes Manages accounts for modules to track the cost of
testing and other consistent with the cost
assigned for cost of laboratory services laboratory services with
laboratory of services and are linked
laboratory services to individual customers customers and to manage the
services to laboratory services
rendered accounts receivable system
rendered

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. Describes billing Verifies that Evaluates centralized Develops workflows and
Integration of functions for multiple accounting of functionality regarding an systems to consolidate
laboratory billing systems that handle laboratory services enterprise-wide capability to cross-enterprise billing and
with billing of laboratory is being collected account for costs accounting for laboratory
services services

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enterprisewide from disparate


billing systems

Performs routine
Generates detailed Develops systems to link
INF 10.05. reporting of billing
Describes billing modules budgetary summaries of billing data for budgeting
Budgeting* and revenue data
billing data and trend analysis
for fiscal analyses

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

Subcompetency Beginner Competent Proficient Expert

Describes centralized Verifies the entry Develops enterprise-wide


Evaluates document
electronic document and timeliness of workflows and
INF 11.01. management systems to
management systems that laboratory program communications to ensure
Document recommend improvements
track and store grants, deliverables into an automated and secure
management and efficiency and to meet
contractual instruments, document document management
systems contractual and grant
and project management* management system for grants and
obligations
materials systems contractual instruments

Creates contractual
Describes informatics
INF 11.02. Verifies the use of instruments with partners
support available to Manages contractual
Contractual existing contractual to ensure informatics and
laboratory through instruments
instruments instruments information technology (IT)
contractual instruments
needs are captured

Tracks activities Evaluates the laboratory's


Develops systems to define,
and deliverables of ability to track delivery of
organize, monitor, and track
Describes informatics grants and individual informatics
INF 11.03. the activities of grants and
contractual and grant contractual components related to
Activity tracking contractual instruments
deliverables instruments using budgetary, personnel, legal,
with outside parties using
predefined and laboratory procedures
electronic processes
electronic modules and processes

Explains
contractual
instruments Evaluates informatics
Develops an enterprise-
INF 11.04. Describes contractual developed for contractual instruments
wide approach to
Enterprise-wide informatics instruments individual with outside parties using
information systems
systems relevant to the enterprise laboratory electronic documentation
implementation
programs for processes
enterprise
management

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

Subcompetency Beginner Competent Proficient Expert

Verifies that
electronic
Evaluates that electronic Develops modules to ensure
Accesses electronic documentation of
INF 12.01. documentation of training, electronic content, access,
information on staff training, education,
Electronic master education, and related and security exist to meet
training, education, and and management of
record* information meets the educational needs of the
capabilities educational
operational requirements laboratory
resources is up-to-
date

INF 12.02. Lists available electronic Verifies that Evaluates the need for Develops modules to ensure
Resource reports that summarize electronic reports additional and revised electronic summary reports
summaries laboratory resources, regarding reports on laboratory of laboratory resources are
including staff laboratory resources available
resources are

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accurate and
complete

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

Evaluates laboratory
Describes informatics Develops informatics programs
Verifies that informatics informatics needs to
systems for tracking to ensure that staff education
INF 12.03. processes remain up-to- ensure the existence
documented staff needs and training is aligned with the
Workforce date and demonstrate of resources and
and knowledge gained business needs and directions
development the acquired informatics avenues to support
from training for laboratory services and the
capabilities of staff staff education and
opportunities professional growth of staff
training

Evaluates electronic
Describes existing Verifies electronic
INF 12.04. training activities for Develops electronic training
electronic documentation on
Training activities external partners to materials and associated
documentation on training activities for
for external ensure they meet documentation for external
trainings offered to external partners are
partners current and future partners
external partners accurate and complete
requirements

Verifies the
Describes own role(s) in Evaluates the Develops a strategy for the
INF 12.05. participation and
supporting the effectiveness of creation, collection, and
Knowledge integration of program
collective knowledge electronic KM management of KM
management staff to ensure
within a laboratory practices performance measures
(KM)* electronic KM within
program organizationally electronically
the organization

Evaluates staff
INF 12.06.
compliance with a
Lifecycle Describes laboratory IT Ensures the use of IT Develops a comprehensive
comprehensive
management project management project management laboratory IT lifecycle
lifecycle management
strategy* for IT resources resources management strategy
strategy for IT
investments
investments

Describes the strategy


for communicating with Develops a strategy for
INF 12.07. Evaluates staff
internal and external Ensures the communication of informatics
Informatics compliance with the
partners regarding implementation of the capabilities and resourcing
communication communication
informatics capabilities communication strategy priorities to internal and
strategy strategy
and resourcing external partners
priorities

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

Verifies the Evaluates electronic


INF 13.01. implementation of data processing
Explains applicable Develops workflows and
Certification, predefined data standards in order to
CAL electronic data modules to automate laboratory
accreditation, and processing standards ensure laboratory
requirements related to adherence to data processing
licensing (CAL) and form management adherence to current
work area standards associated with CAL
compliance associated with CAL for and new CAL
a laboratory program requirements

INF 13.02. Enters data into Verifies performance of Evaluates current Develops electronic modules to
External predefined modules predefined electronic capabilities to manage automate the management of

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certification systems regarding external certifications external certifications


external certifications and future needs

Describes electronic
Ensures that individual Evaluates individual Develops workflows and
standards for own job
laboratory programs electronic security and modules to ensure electronic
INF 13.03. Privacy classification related to
adhere to electronic privacy standards that systems meet security and
and security the privacy and security
security and privacy the laboratory must privacy standards and adhere to
of protected
standards meet regulatory requirements
information*

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

INF 14.00. Customer relationship management: manages customer relationships

Subcompetency Beginner Competent Proficient Expert

Evaluates current and


Develops workflow and
Describes Verifies the future needs to handle
modules that automate the
14.01. Tracking predefined implementation of customer relationships and
collection of data to track and
customer and modules to record predefined modules to perform ad hoc queries to
to perform ad hoc queries
staff feedback customer and staff record customer and staff improve regulatory
and reporting of customer
feedback feedback compliance and business
and staff feedback
management

Develops workflow and


Describes
INF 14.02. Verifies the Evaluates current and modules that automate the
predefined
Tracking implementation of future needs to track and collection of data to track and
modules to record
laboratory errors predefined modules to perform ad hoc queries on to perform ad hoc queries
laboratory errors
and information record laboratory errors laboratory errors and and reporting of laboratory
and information
requests and information requests information requests errors and information
requests
requests

Describes Verifies the Develops workflow and


Evaluates current and
INF 14.03. predefined implementation of modules that automate the
future needs to track,
Tracking modules that predefined modules to collection of data to track and
perform ad hoc queries,
corrective actions summarize summarize corrective to perform ad hoc queries
and provide reports
and reports reporting and actions and generate and reporting of correction
regarding corrective actions
corrective actions reports actions

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

Subcompetency Beginner Competent Proficient Expert

Verifies the electronic set-


Describes
up, extraction, and
INF 15.01. QC predefined Evaluates automated
transmission of QC data Develops automated
data associated modules that systems for QC data set up,
using predefined modules processes for QC data set up,
with sample collect QC data extraction, and
and data capture utilities extraction, and transmission
results associated with transmission
for automated
sample results
instruments

Lists QC data that


Validates final data prior to Develops workflows and
INF 15.02. Data are collected
Performs review and release to customers using modules to assist in
review and electronically to
validation of data configurable rules-based automating the validation of
validation support validation
functionality test results
of test results

INF 15.03. Data Enters QC data to Verifies the use of Evaluates automated Develops the workflows and
trending support tracking, automated software to tracking, trending, and automation processes to
trending, and support analysis of QC analysis of method accuracy support automated tracking,
analysis of method data related to tracking, and precision trending, and analysis of
trending, and analysis of

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accuracy and method accuracy and method accuracy and


precision precision precision

Uses predefined
Develops reports that meet
modules to Verifies the reporting and
Evaluates automated method requirements and
produce electronic evaluation of QC data
INF 15.04. QC reporting of QC data customer needs to capture
and paper results associated with analytical
reporting associated with analytical and deliver QC data in
that include QC testing using predefined
batches multiple formats and
data associated modules
messages
with test runs

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

Evaluates
Performs day-to-day Develops informatics
organizational
Describes organizational oversight of workflows and the
structure, policies,
INF 15.05. QA structure, policies, organizational structure, organizational structure,
processes,
and quality processes, procedures, and policies, processes, policies, processes,
procedures, and
management resources that address QA procedures, and procedures, and resources
resources that
systems (QMS)* related to informatics resources that address to address QMS and QA
address QA- and
activities QA- and QMS-related to related to informatics
QMS-related to
informatics activities activities
informatics activities

Validates data
Verifies that data to elements using
Describes data elements Develops automated
support auto-alerts, configurable rules-
INF 15.06. needed to support workflows to provide auto-
qualifiers, or triggering of based functionality to
Responses to QC automated auto-alerts, alerts, qualifiers, and
responses to QC data are provide auto- alerts,
data qualifiers, or triggering of triggering of responses to
associated with test qualifiers, or
responses to QC data QC data
results triggering of
responses to QC data

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

Subcompetency Beginner Competent Proficient Expert

Describes electronic data


entry and access to Verifies the central
INF 16.01. hazardous material management of Evaluates the Develops an electronic,
Hazardous locations, safety data sheets hazardous materials electronic, centralized centralized system to
materials* (SDS),* procedures, using predefined management of manage hazardous
management disposal records* current electronic modules for hazardous materials materials
practice standards, and reporting and tracking
master records

Ensures staff compliance Manages laboratory Develops electronic


with electronic reporting electronic safety and workflows, processes, and
INF 16.02. Describes predefined
of laboratory safety accident investigation procedures to track and
Incident* tracking modules to track incidents
activities and accident processes and manage safety and
investigations procedures accident investigations

Ensures staff compliance Evaluates automated


Describes predefined Develops electronic
INF 16.03. Select with regulations processes to adhere to
modules related to the modules that adhere to the
agent* associated with the the federal Select
federal Select Agent federal Select Agent
management federal Select Agent Agent Program and
Program* and registry Program and registry
Program and registry registry

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INF 16.04. Describes system alerts Verifies the generation of Evaluates current and Develops electronic
Hazardous associated with hazardous package and sample future electronic modules to manage and
material alerts* materials labels once an alert is hazardous material track activities associated
received electronically alert requirements with hazardous material
alerts

Evaluates the
Lists electronic central Verifies that
documentation Develops task workflow
INF 16.05. documents that define documentation systems
systems for laboratory analyses to ensure the
Hazardous risk laboratory processes related track laboratory processes
processes related to electronic management of
management to hazardous risk related to hazardous risk
hazardous risk hazardous risks
management management
management

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

Evaluates the
Verifies that laboratory informatics and IT
INF 17.01. Outlines coverage of Develops informatics COOP
program responsibilities aspects of the
Continuity of informatics and IT workflows and procedures to
are carried out during the laboratory COOP to
Operations Plan services within the restore informatics and IT
implementation of a ensure they are
(COOP)* laboratory's COOP support
COOP complete and up-to-
date

Manages the
documentation
Verifies the performance supporting existing Develops work plans and
of laboratory program informatics project management
INF 17.02. COOP Describes COOP formal
informatics contractual processes to ensure that
contractual contractual instruments
responsibilities instruments comprehensive informatics
instruments involving informatics
pertaining to COOP pertaining to disaster contractual instruments are
contractual instruments recovery and mutual in place
assistance through
drills

Develops workflows and


Explains the importance Verifies the accuracy and Evaluates electronic
project management
of a catalogue of access to a catalogue of catalogue capabilities,
INF 17.03. processes to validate the
electronic capabilities electronic capabilities, services, and
Electronic electronic catalogue of
and services, and of services, and schedules schedules for testing
catalogue of capabilities, services,
schedules for testing for testing their their effectiveness
capacities and schedules, and testing of
their effectiveness during effectiveness during during disaster
services effectiveness during disaster
disaster recovery and disaster recovery and recovery and
recovery and emergency
emergency situations emergency situations emergency situations
situations

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

Subcompetency Beginner Competent Proficient Expert

Evaluates
Employs client-side
modifications,
INF 18.01. Client- computer systems Verifies the correct use of Evaluates client-side options
upgrades, and new
side systems and including LIMS access LIMS and advanced use regarding LIMS installation,
releases to laboratory
software protocols and routine of office software management, and use
instrument software
office software
and systems

INF 18.02. Describes Determines content for Evaluates the use and Develops the technology to
Electronic communication tools for electronic information requirements of support electronic
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communication electronic information communication tools electronic information information communication


communication tools tools

Verifies LIMS processes Manages the continuous


Evaluates LIMS
INF 18.03. for data collection, data availability and development
Describes LIMS functionality to meet
Enterprise-wide processing and reporting of an enterprise-wide LIMS to
management processes laboratory and
LIMS availability for laboratory business ensure a fully functional and
customer needs
needs mature system

Describes network access Verifies laboratory use of Evaluates the use of


INF 18.04. Manages the administration
protocols and use of the predefined network networks to support
Networking of network servers
laboratory network protocols laboratory activities

Develops formal contractual


instruments, workflows, and
Documents the delivery Evaluates IT support
INF 18.05. IT help Describes access to project management
of support to laboratory needed for laboratory
desk available IT support processes for the delivery of
programs operations
IT support throughout the
laboratory

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

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

Subcompetency Beginner Competent Proficient Expert

Describes the processes


INF 18.06.
to use and improve Evaluates the Manages the SDLC at the
Software Verifies needs for software
electronic laboratory resources that enterprise-level, including
development life process improvements
workflows and impact the SDLC change management*
cycle (SDLC)*
algorithms

Develops automated
INF 18.07. Evaluates
Lists predefined Verifies the use of workflows and processes
Enterprise integration functions
functions that use an predefined integration regarding data capture and
integration with partners and
integration engine engine modules use of an integration engine to
engine* customers
message data

Evaluates the Develops workflows and


INF 18.08. Legacy Defines legacy data Verifies access to, and use accessibility and processes to ensure that
data systems* systems of, legacy data systems searchability of legacy data are accessible and
legacy data searchable

Describes predefined Verifies the proper use of Evaluates the ability


INF 18.09. LIMS Develops workflows and
modules to support predefined modules to of the LIMS to
communication processes to support LIMS
LIMS communication support LIMS communicate with
with third-party communications with third-
with third-party data communication with third- third-party data
data systems party systems
systems party data systems systems

Evaluates the ability


Describes modules that
INF 18.10. Access Verifies staff access to of the LIMS to Develops protocols to manage
provide a view of audit
and audit trails electronic audit trails manage access and access and audit trails
trails
audit trails

INF 18.11. Describes instrument


Uses instrument analysis Evaluates analytical Develops analytical
Instrument analysis software
software instrument software instrument software systems
analysis software systems

INF 18.12. Identifies basic Performs routine computer Performs complex Manages the computer
Computer computer problems maintenance and computer maintenance and
maintenance and troubleshooting maintenance and troubleshooting processes
troubleshooting troubleshooting

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

Subcompetency Beginner Competent Proficient Expert

Ensures laboratory program


INF 19.01. Describes existing Evaluates Develops processes for
adherence to existing
Informatics policy informatics policies informatics policies informatics policy making
informatics policies

Evaluates the
Ensures laboratory program Develops informatics policies,
Describes change effectiveness of
INF 19.02. adherence to the change processes, and procedures to
control processes change control
Change control¶ control processes related to manage change control and
related to informatics processes related to
informatics ensure staff compliance
informatics

Evaluates
INF 19.03. Verifies that paper and Develops workflows and
Provides completeness of
Documentation electronic documentation of processes to ensure paper and
documentation for documentation for
for standardized laboratory IT processes are electronic documentation is
standardized laboratory standardized
laboratory IT centrally located and centrally located and
IT processes laboratory IT
processes accessible accessible
processes

Identifies informatics
INF 19.04. Describes the Develops a budgeting strategy
business needs of the Evaluates the
Operational importance of for the laboratory's
laboratory program for operational
budgeting electronic budgetary informatics systems and
operational budgeting budgeting strategy
strategy processes services
strategizing

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

Describes the capital Provides the listing of Develops capital


Evaluates capital budgeting
INF 19.05. Capital budgeting processes capital budget needs budgets for electronic
needs regarding laboratory
budgeting* for informatics- regarding laboratory information systems
informatics
related assets* informatics and services

Presents short- and Ensures that laboratory


INF 19.06. Lists established Develops partnerships
long-term informatics informatics business needs are
Partnership stakeholders and to facilitate funding
business needs to presented to stakeholders and
channels partnership channels for informatics
management staff 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.

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. Describes basic Relates Ensures Evaluates laboratory practices for
Microbiological microbiological microbiological microbiological adherence to accepted microbiological
concepts and concepts and theories concepts and theories
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concepts and concepts and theories to the are applied in


theories* theories specific tests that are laboratory testing
conducted

Integrates basic
Applies basic
MCB 1.02. Basic microbiological Trains staff on basic Ensures implementation of basic
microbiological
microbiological techniques into new microbiological microbiological techniques into
techniques to
techniques laboratory practices techniques laboratory practices
laboratory testing
and procedures*

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

Subcompetency Beginner Competent Proficient Expert

Recognizes Instructs others on Ensures staff


MCB 2.01. laboratory hazards laboratory hazards compliance with
Develops policies, processes, and
Laboratory and hazard and hazard policies, processes,*
procedures regarding hazards related
hazards related to communication* communication and procedures
to microbial agents based on risk
microbiological related to related to addressing laboratory
assessments†
agents microbiological microbiological hazards related to
agents agents microbiological agents

Adheres to policies, Instructs others in Ensures staff Creates a culture of biosafety by


processes, and policies, processes, compliance with ensuring that policies, processes, and
procedures and procedures policies, processes, and procedures regarding safe work
MCB 2.02. Safe
regarding safe work regarding safe work procedures regarding practices related to microbiological
work practices*
practices related to practices related to safe work practices agents are aligned with current
microbiological microbiological related to standards and regulatory
agents agents microbiological agents requirements

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

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

Subcompetency Beginner Competent Proficient Expert

Adheres to policies, Instructs staff in


processes, and policies, processes, Ensures staff compliance with Establishes policies,
MCB 2.03.
procedures regarding and procedures policies, processes, and processes, and procedures
Personal
PPE use for work regarding PPE use procedures regarding PPE use regarding PPE use for work
protective
related to for work related to for work related to related to microbiological
equipment (PPE)*
microbiological microbiological microbiological agents agents
agents agents

Ensures laboratory adherence


Establishes policies,
Adheres to policies, to biosafety cabinet
MCB 2.04. processes, and procedures,
processes, and Instructs staff in use certification* and staff
Biosafety cabinets including training, to
procedures regarding of biosafety cabinets compliance with policies,
and other ensure implementation and
the use of biosafety and other processes, and procedures
engineering use of biosafety cabinets
cabinets and other engineering controls regarding the use of biosafety
controls* and other engineering
engineering controls cabinets and other engineering
controls
controls

Adheres to policies, Instructs staff in


MCB 2.05. Waste processes, and waste management
Establishes waste management
management procedures regarding policies, processes, Oversees the waste
processes and procedures
related to waste management and procedures management plan* related
related to microbiological
microbiological related to related to to microbiological agents
agents
agents microbiological microbiological
agents agents

MCB 2.06. Adheres to policies, Instructs staff in the Ensures staff compliance with Develops policies,

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Decontamination* processes, and policies, processes, policies, processes, and processes, and procedures
procedures regarding and procedures procedures regarding related to decontamination
decontamination regarding decontamination
decontamination for
different
microorganisms

Instructs staff in
Adheres to policies, policies, processes,
Ensures staff compliance with
MCB 2.07. processes, and and procedures Develops policies,
policies, processes, and
Storage of procedures regarding regarding the storage processes, and procedures
procedures that address the
microbiological storage of of microbiological related to the storage of
storage of microbiological
materials microbiological materials for microbiological materials
materials
materials different
microorganisms

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

Subcompetency Beginner Competent Proficient Expert

Describes routine
Consults on
sample collection, Monitors staff compliance with Oversees the policies,
nonroutine sample
MCB 3.01. Sample labeling, and established policies, processes, processes, and procedures
collection, labeling,
collection, handling policies, and procedures regarding for sample collection,
and handling
labeling, and processes, and microbiological sample labeling, and handling for
procedures for
handling procedures for collection, labeling, and microbiological
microbiological
microbiological handling examination
examination
examination

Develops policies,
Ensures staff compliance with
Performs packing Instructs others on processes, and procedures
policies, processes, and
MCB 3.02. and shipping of packing and shipping to ensure staff compliance
procedures regarding the
Packaging and Category A* and of Category A and with packing and shipping
packing and shipping of
shipping Category B* Category B infectious regulations concerning
Category A and Category B
infectious substances substances Category A and Category B
infectious substances
infectious substances

Describes the
importance of
Instructs others on
adhering to Oversees the policies,
microbiological Develops microbiological
MCB 3.03. established policies, processes, and procedures
material transport material transport processes
Material transport processes, and regarding microbiological
policies, processes, and procedures
procedures regarding material transport
and procedures
microbiological
material transport

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

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

Subcompetency Beginner Competent Proficient Expert

Describes policies,
Adheres to policies, Oversees the policies,
processes, and Ensures staff compliance
processes, and processes, and
procedures for the with policies, processes, and
procedures regarding the procedures regarding the
identification, procedures regarding the
MCB 3.04. identification, handling, identification, handling,
handling, safety, identification, handling,
Biological threats safety, appropriateness safety, appropriateness
appropriateness and safety, appropriateness and
and triage of samples and triage of samples
triage of samples triage of samples containing
containing agents of containing agents of
containing agents of agents of concern
concern concern
concern

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MCB 3.05. Performs procedures Instructs staff in policies, Develops processes and Oversees the policies,
Accessioning and for accessioning and processes, and procedures for processes, and
receipt receipt of procedures regarding microbiological sample procedures regarding
microbiological accessioning and receipt accessioning and receipt microbiological sample
samples of microbiological accessioning and receipt
samples

Instructs staff on Oversees the policies,


Develops processes and
Performs systematic policies, processes, and processes, and
procedures for the
tracking of procedures for the procedures for the
MCB 3.06. systematic tracking of
microbiological systematic tracking of systematic tracking of
Sample tracking microbiological samples
samples from receipt to microbiological samples microbiological samples
from receipt to final
final disposition from receipt to final from receipt to final
disposition
disposition disposition

Oversees the policies,


Instructs others in the processes, and
MCB 3.07. Assesses sample Develops processes and
appropriateness of procedures regarding
Sample evaluation appropriateness for a procedures for assessment
routine and nonroutine assessment of routine
and particular of routine and nonroutine
samples for and nonroutine sample
appropriateness* microbiological sample appropriateness for
microbiological appropriateness for
for testing examination microbiological examination
examination microbiological
examination

Adheres to policies, Instructs staff in policies, Ensures staff compliance Establishes policies,
MCB 3.08. processes, and processes, and with policies, processes, and processes, and
Testing workflow§ procedures regarding procedures regarding procedures related to testing procedures related to
testing workflow testing workflow workflow testing workflow

MCB 3.09. Instructs staff in policies,


Nucleic Acid Adheres to policies, processes, and Ensures staff compliance Establishes policies,
Amplification processes, and procedures regarding with policies, processes, and processes, and
Tests (NAAT) procedures regarding NAAT workflow, procedures regarding NAAT procedures for NAAT
workflow (facility NAAT workflow including pre- and workflow workflow
specific) postamplification areas

Oversees the policies,


Develops processes and
Performs sample set-up Instructs staff in sample processes, and
procedures regarding
MCB 3.10. Sample procedures for set-up for procedures regarding
sample set-up for
set-up microbiological microbiological sample set-up for
microbiological
examinations examinations microbiological
examinations
examinations

Oversees the policies,


Performs procedures Instructs staff in Develops processes and
processes, and
MCB 3.11. Sample for microbiological procedures for procedures for
procedures regarding
storage and sample storage and microbiological sample microbiological sample
microbiological sample
handling handling prior to storage and handling storage and handling prior
storage and handling
examination prior to examination to examination
prior to examination

Oversees the policies,


Ensures staff compliance
Describes which processes, and
Reports to with policies, processes, and
microbiological procedures for
MCB 3.12. epidemiologists when procedures for notification
examination requests notification and
Epidemiologic microbiological and consultation with
require epidemiologic consultation with
collaboration examination requests epidemiologists regarding
notification and epidemiologists
warrant notification microbiological examination
consultation regarding microbiological
requests
examination requests

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

MCB 4.00. Examination:* assesses microbiological samples during the examination phase
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Subcompetency Beginner Competent Proficient Expert

Prepares
culture media Ensures staff compliance with Oversees the policies,
MCB 4.01.
according to Instructs staff on the policies, processes, and processes, and
Preparation of
policies, preparation of culture media procedures regarding quality procedures for media
culture media
processes, and practices for media preparation preparation
procedures

Ensures staff compliance with Oversees the policies,


Selects media
MCB 4.02. Instructs staff in the media policies, processes and processes, and
according to
Selection of media selection process procedures regarding quality procedures regarding
procedures
practices for media selection media selection

Performs
Ensures staff compliance with Oversees the policies,
MCB 4.03. culture Instructs staff in how to
policies, processes and processes, and
Culture inoculation inoculate cultures using
procedures regarding quality procedures regarding
inoculation using aseptic aseptic technique
practices for culture inoculation culture inoculation
techniques

MCB 4.04. Recognizes the Ensures staff compliance with Oversees the policies,
Instructs staff in
Microscopic morphological policies, processes and processes, and
morphological identification
examination with characteristics procedures regarding quality procedures regarding
and differentiating organisms
morphological of different practices for morphological morphological
from artifacts
characteristics organisms identification identification

Ensures staff compliance with Oversees the policies,


Recognizes
policies, processes and processes, and
MCB 4.05. growth Instructs staff in identifying
procedures regarding quality procedures for
Culture growth characteristics growth characteristics of
practices for identifying interpretation of
characteristics of microorganisms
microorganism growth microorganism growth
microorganisms
characteristics characteristics

Performs Oversees the policies,


Ensures staff compliance with
MCB 4.06. identification processes, and
Instructs staff in the policies, processes, and
Manual and procedures regarding the
performance of identification procedures regarding quality
identification* susceptibility performance of
and susceptibility testing practices for performing
and susceptibility testing using identification and
using manual methods identification and susceptibility
testing* methods manual susceptibility testing
testing using manual methods
methods using manual methods

Performs Instructs staff in the Ensures staff compliance with Oversees the policies,
MCB 4.07. identification performance of identification policies, processes, and processes, and
Automated and and susceptibility testing procedures regarding quality procedures regarding the
identification* susceptibility using automated systems, practices for performing performance of
and susceptibility testing using including how to utilize identification and susceptibility identification and
testing* systems automated algorithms to determine testing using automated susceptibility testing
systems additional testing systems using automated systems

Ensures staff compliance with


Performs Oversees the policies,
MCB 4.08. Agent- Instructs staff in how to policies, processes, and
antigen processes, and
specific antigen perform antigen detection procedures regarding quality
detection procedures for antigen
detection* methods practices for antigen detection
methods detection
methods

Ensures staff compliance with


Oversees the policies,
Instructs staff in the policies, processes, and
MCB 4.09. Performs NA processes, and
performance of NA procedures regarding quality
Nucleic acid (NA) sequencing of procedures regarding NA
sequencing for the practices for NA sequencing of
sequencing of infectious sequencing and
identification of infectious infectious agents, including the
infectious agents agents sequence-based
agents selection and utilization of
identification
databases

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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

Ensures staff compliance


with policies, processes, Oversees the policies,
MCB 4.10. Strain Instructs staff in how to
Performs strain typing and procedures regarding processes, and procedures
typing methods* perform strain typing
quality practices for strain regarding strain typing
typing

Performs rule-out testing


Explains the policies, Ensures the laboratory
and referral for Oversees the policies,
MCB 4.11. Rule- processes, and responds quickly to needs
identification, processes, and procedures
out testing for procedures regarding for rapid testing with
confirmation, and regarding rule-out testing
agents of concern rule-out testing and timely notification and
characterization of and referral
referral secure messaging of results
agents of concern

MCB 4.12. Quality Examines QC data over Ensures the QC program


Interprets QC data prior
control (QC)* Performs QC activities time to establish QC ranges adheres to regulatory
to reporting results
analysis and limits requirements*

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

Subcompetency Beginner Competent Proficient Expert

Ensures staff compliance Oversees the policies,


Evaluates QC data for a
MCB 5.01. QC Assembles QC data for with established policies, processes, and procedures
given data reporting
evaluation evaluation processes, and procedures related to QC evaluation
period
for QC evaluation activities activities

Oversees the policies,


MCB 5.02. Test
processes, procedures,
analysis and Assembles test data for Interprets complex or
Analyzes test data and algorithms related to
results review and action ambiguous results
data analysis and results
interpretation
interpretation

Oversees the policies,


Adheres to policies, Instruct staff in the Ensures staff compliance
processes, and
processes and policies, processes, and with policies, processes and
MCB 5.03. procedures, related to
procedures related to procedures related to procedures related to
Results reporting reporting and release of
reporting and release of reporting and release of reporting and release of
and data release examination results and
examination results examination results and examination results and
notifiable results to
and notifiable results* notifiable results notifiable results
partners

MCB 5.04. Explains the Collects data for Oversees the policies,
Evaluates QA indicator
Quality assurance differences between QA reporting on QA processes, and procedures
data
(QA)* and QC indicators related to QA

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

MCB 6.00. Regulatory compliance: ensures regulatory compliance

Subcompetency Beginner Competent Proficient Expert

MCB 6.01.
Documents NCEs on discovery Analyzes NCEs for Designs a
Nonconforming Recognizes NCEs in laboratory
for implementation of corrective actions management
event (NCE)* processes
corrective actions and documentation system for NCEs
tracking

MCB 6.02. Performs PT and alternative Reviews PT and alternative Monitors to ensure Oversees the
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Proficiency testing assessment assessment results the PT and policies, processes,


(PT)* and alternative and procedures
alternative assessment related to PT and
assessment* program meets alternative
regulatory assessments
requirements

Oversees the
MCB 6.03. policies, processes,
Evaluates method
Method Participates in performance of Compiles results of method and procedures
validation and
validation* and method validation and validation and performance related to method
performance
performance performance verification verification validation and
verification results
verification* performance
verification

MCB 6.04. Oversees the


Creates processes
Development and policies, processes,
and procedures for
validation of Participates in the and procedures
Evaluates LDT validation data the development
laboratory- development of LDTs regarding the
and validation of
developed tests development and
LDTs
(LDTs)* validation of LDTs

Implements Oversees select


Describes the policies, Complies with policies,
policies, processes, agent security,
processes, and procedures processes, and procedures
and procedures biosafety, testing,
related to the federal Select related to the federal Select
MCB 6.05. Select regarding select and incident
Agent Program,* including the Agent Program, including the
agents* agent security, response plans to
securing, safe handling, and securing, safe handling, and
biosafety, testing, ensure alignment
testing of select agents and the testing of select agents and the
and incident with select agent
documentation of activities documentation of activities
response plans* regulations

* This term is defined in Appendix B.


† The evaluation of the probability and consequences of exposure to a given hazard, with the intent to reduce the risk by
establishing the appropriate hazard controls to be used.
§ Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured
in the report of results, including pre-examination, examination, and postexamination procedures.

TABLE 13. Public health laboratory competency guidelines: Chemistry domain

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

Subcompetency Beginner Competent Proficient Expert

Integrates new understandings of


Applies knowledge of Integrates knowledge Differentiates
CHM 1.01. chemical properties to address
the properties of of the properties of chemical properties
Chemical occupational exposures or
matter to assist in matter into new to improve chemical
properties environmental or other public health
chemical analyses chemical analyses analyses
issues

CHM 1.02. Differentiates


Describes chemical Applies chemical Formulates new chemical concepts to
Chemical chemical concepts in
concepts concepts to analyses improve determinations
concepts analyses

CHM 1.03. Explains statistical Evaluates


Collects data for Oversees the development and use of
Laboratory concepts and summarized data for
statistical analyses statistical programs
statistics practices statistical analyses

CHM 1.04. Performs chemical Instructs staff in the Determines when Oversees the use and interpretation of

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Equations and calculations performance of and which chemical chemical equations and calculations
calculations chemical calculations equations and
calculations are
needed

Performs Instructs staff in Determines the Develops processes* and procedures*


CHM 1.05. measurements and measurements and needed accuracy and to maximize the accuracy and
Measurements unit conversion unit conversion precision of precision of measurements and
calculations calculations measurements techniques

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

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

Subcompetency Beginner Competent Proficient Expert

Recognizes chemical
Instructs others on Implements hazard Develops strategies to
CHM 2.01. hazards and chemical
chemical hazards and communication reduce chemical hazards
Chemical hazards hazard
hazard communication procedures and training based on risk assessments†
communication*

Creates a culture of safety by


ensuring that policies,
Ensures staff compliance
Instructs others in safe processes, and procedures
Adheres to safe work with policies,* processes,
CHM 2.02. Safe work practices, policies, regarding safe work
practices related to and procedures related to
work practices* and procedures related practices related to chemical
chemical hazards safe work practices related
to chemical hazards hazards are aligned with
to chemical hazards
current standards and
regulatory requirements

Ensures that staff are


CHM 2.03. Adheres to policies,
trained and comply with Establishes policies,
Personal processes, and Instructs staff in the use
policies, processes, and processes, and procedures
protective procedures regarding of PPE
procedures regarding the regarding the use of PPE
equipment (PPE)* PPE use
use of PPE

Adheres to policies, Ensures that staff are


Establishes policies,
CHM 2.04. processes, and trained and comply with
Instructs staff in the use processes, and procedures
Engineering procedures regarding policies, processes, and
of engineering controls regarding the use of
controls* the use of engineering procedures regarding the
engineering controls
controls use of engineering controls

Adheres to policies,
CHM 2.05. Waste Instructs staff in sample
processes, and Establishes sample waste
management waste management Oversees the sample waste
procedures related to management policies,
related to policies, processes, and management plan*
sample waste processes, and procedures
samples* procedures
management

CHM 3.00. Pre-examination:* performs chemistry pre-examination procedures

Subcompetency Beginner Competent Proficient Expert

Describes routine Monitors staff compliance


Consults on nonroutine Oversees the policies,
CHM 3.01. sample collection, with established policies,
sample collection, processes, and procedures
Sample collection, labeling, and handling processes, and procedures
labeling, and handling for the collection and
labeling, and policies, processes, and regarding chemical sample
procedures for chemical handling of samples for
handling procedures for collection, labeling, and
examination chemical examination
chemical examination handling

CHM 3.02. Performs the packing Instructs others on Ensures staff compliance Develops policies, processes,
Packaging and and shipping of packing and shipping of with policies, processes, and procedures to ensure
shipping hazardous samples hazardous samples and procedures regarding staff compliance with

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the packing and shipping packing and shipping


of hazardous samples regulations concerning
hazardous samples

Describes the
importance of adhering
Oversees the policies,
to established policies, Instructs others on
Develops material processes, and procedures
CHM 3.03. processes, and material transport
transport processes and for the transport of
Material transport procedures regarding policies, processes, and
procedures materials for chemical
transport of materials procedures
examination
for chemical
examination

Describes the policies, Adheres to policies,


Ensures staff compliance
processes, and processes, and Oversees the policies,
with policies, processes,
procedures for the procedures regarding processes, and procedures
and procedures regarding
identification, the identification, regarding the identification,
CHM 3.04. the identification,
handling, safety, handling, safety, handling, safety,
Chemical threats handling, safety,
appropriateness and appropriateness and appropriateness and triage
appropriateness and triage
triage of samples triage of samples of samples containing
of samples containing
containing chemical containing chemical chemical agents of concern
chemical agents of concern
agents of concern agents of concern

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

CHM 3.00. Pre-examination:* performs chemistry pre-examination procedures

Subcompetency Beginner Competent Proficient Expert

Performs Instructs staff on


Manages the policies, Designs policies, processes,
CHM 3.05. procedures for policies, processes, and
processes, and procedures and procedures regarding
Accessioning and sample procedures regarding
for sample accessioning and sample accessioning and
receipt accessioning and sample accessioning
receipt receipt
receipt and receipt

Instructs staff on
Performs Manages the policies, Designs polices, processes,
policies, processes, and
systematic tracking processes, and procedures and procedures for the
CHM 3.06. procedures for the
of samples from for the systematic tracking systematic tracking of
Sample tracking systematic tracking of
receipt to final of samples from receipt to samples from receipt to final
samples from receipt to
disposition final disposition disposition
final disposition

Manages the policies, Establishes policies,


CHM 3.07. Assesses Instructs others in
processes, and procedures processes, and procedures
Sample evaluation appropriateness of appropriateness of
for assessment of routine regarding the assessment of
and routine samples for routine and nonroutine
and nonroutine sample routine and nonroutine
appropriateness* chemical samples for chemical
appropriateness for sample appropriateness for
for testing examination examination
chemical examination chemical examination

Adheres to policies,
Instructs staff in Ensures laboratory
processes, and Develops policies, processes,
CHM 3.08. policies, processes, and processes and procedures
procedures and procedures related to
Testing workflow§ procedures regarding include use of testing
regarding testing testing workflow
testing workflow workflow
workflow

Performs sample Develops policies, processes,


Instructs staff on sample
CHM 3.09. processing Performs sample and procedures regarding
processing for routine and
Sample procedures for processing for complex sample processing for routine
complex chemical
processing routine chemical chemical examinations and complex chemical
examinations
examinations examinations

CHM 3.10. Pre- Performs Instructs staff in Manages processes and Designs policies, processes,
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examination procedures for procedures for sample procedures for sample and procedures regarding
sample storage sample storage and storage and handling storage and handling prior sample storage and handling
and handling handling prior to prior to examination to examination prior to examination
examination

Describes which Manages the policies,


Designs policies, processes,
chemical Reports to processes, and procedures
and procedures regarding
CHM 3.11. examination epidemiologists when for notification and
notification and consultation
Epidemiologic requests require chemical examination consultation with
with epidemiologists
collaboration epidemiologic requests warrant epidemiologists regarding
regarding chemical
notification and notification chemical examination
examination requests
consultation requests

CHM 4.00. Examination:* performs chemistry examination procedures

Subcompetency Beginner Competent Proficient Expert

Monitors staff compliance


Performs chemistry Instructs staff in Oversees chemistry
CHM 4.01. with chemistry examination
examination chemistry examination examination policies,
Examination policies, processes, and
procedures procedures processes, and procedures
procedures

CHM 4.02. Performs routine


Performs nonroutine Selects chemical extractions Develops new and improved
Chemical chemical extraction
chemical extractions for an identified purpose types of chemical extractions
extractions methods

CHM 4.03. Examines QC data over time Ensures the QC program


Performs QC Interprets QC data prior
Quality control to establish QC ranges and adheres to regulatory
activities to reporting results
(QC)* analysis limits requirements*

Identifies basic
CHM 4.04. Monitors equipment Develops equipment
laboratory Corrects equipment
Equipment functioning during its troubleshooting processes
equipment* problems or failures
troubleshooting lifecycle and procedures
problems

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

CHM 4.00. Examination:* performs chemistry examination procedures

Subcompetency Beginner Competent Proficient Expert

Designs policies,
CHM 4.05. Performs procedures Instructs staff in Manages processes and
processes, and procedures
Sample storage for sample storage and procedures for sample procedures for sample
for sample storage and
and handling after handling after storage and handling storage and handling after
handling after
examination examination after examination examination
examination

CHM 5.00. Postexamination:* performs chemistry postexamination procedures

Subcompetency Beginner Competent Proficient Expert

Ensures staff compliance Oversees the policies,


Evaluates QC data for a
CHM 5.01.QC Assembles QC data for with established policies, processes, and procedures
given data reporting
evaluation evaluation processes, and procedures related to QC evaluation
period
for QC evaluation activities activities

Oversees the policies,


CHM 5.02. Test
processes, procedures, and
analysis and Assembles test data for Interprets complex or
Analyzes test data algorithms related to data
results review and action ambiguous results
analysis and results
interpretation
interpretation

CHM 5.03. Adheres to policies, Instruct staff in the Ensures staff compliance Oversees the policies,
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Results reporting processes and policies, processes, and with policies, processes processes, and procedures,
and data release procedures related to procedures related to and procedures related to related to reporting and
reporting and release of reporting and release of reporting and release of release of examination
examination results examination results and examination results and results and notifiable
and notifiable results* notifiable results notifiable results results to partners

CHM 5.04. Explains the Collects data for Oversees the policies,
Evaluates QA indicator
Quality assurance differences between QA reporting on QA processes, and procedures
data
(QA)* and QC indicators related to QA

CHM 6.00. Regulatory compliance: ensures regulatory compliance

Subcompetency Beginner Competent Proficient Expert

CHM 6.01. Documents NCEs on


Analyzes NCEs for
Nonconforming Recognizes NCEs in discovery for Designs a management
corrective actions and
event (NCE)* laboratory processes implementation of system for NCEs
documentation
tracking corrective actions

CHM 6.02.
Monitors to ensure the PT Oversees the policies,
Proficiency testing Reviews PT and
Performs PT and and alternative assessment processes, and procedures
(PT)* and alternative assessment
alternative assessment program meets regulatory related to PT and
alternative results
requirements alternative assessments
assessment*

CHM 6.03. Participates in Oversees the policies,


Evaluates method
Method performance of method Compiles results of processes, and procedures
validation and
validation* and validation and method validation and related to method
performance verification
performance performance performance verification validation and
results
verification* verification performance verification

CHM 6.04.
Oversees the policies,
Development and Creates processes and
processes, and procedures
validation of Participates in the Evaluates LDT validation procedures for the
regarding the
laboratory- development of LDTs data development and
development and
developed tests validation of LDTs
validation of LDTs
(LDTs)*

* This term is defined in Appendix B.


† The evaluation of the probability and consequences of exposure to a given hazard, with the intent to reduce the risk by
establishing the appropriate hazard controls to be used.
§ Sequential steps in a laboratory's activities that transform a submitter's test order into the laboratory information captured
in the report of results, including pre-examination, examination, and postexamination procedures.

TABLE 14. Public health laboratory competency guidelines: Bioinformatics domain

BIO 1.00. Biology and computer science knowledge: integrates knowledge of biology and computer science

Subcompetency Beginner Competent Proficient Expert

Identifies potential Evaluates the effectiveness


Selects biological
BIO 1.01. biological problems to Determines biological of the selected computer
problems to be
Domain-specific be addressed by problems to be addressed by science technique(s) in
addressed by computer
biology principles computer science computer science techniques addressing biological
science techniques
techniques problems

BIO 1.02. Identifies computer Applies computer science Evaluates computer Develops new
Domain-specific science domains* to domains to biological science domains to apply understandings of
computer science apply to biological problems to biological problems computer science
principles problems domains to apply to
biological problems

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BIO 2.00. Statistical methods knowledge: applies knowledge of statistical methods for analysis of biological
data

Subcompetency Beginner Competent Proficient Expert

Uses simple statistical Oversees selection of


analysis to analyze trends advanced statistical
BIO 2.01. Prepares data for Compares findings to any
and patterns and to draw methods applicable to
Statistical analysis processing related data sets
conclusions related to the specific bioinformatics
biological data analyses

TABLE 14. (Continued) Public health laboratory competency guidelines: Bioinformatics domain

BIO 3.00. Data analysis: analyzes biological data

Subcompetency Beginner Competent Proficient Expert

Implements new
Selects which existing Determines options and
software tools to
BIO 3.01. Data tools and algorithms parameters of tools to
address unmet needs Creates stand-alone analysis tools
analysis to use for any given meet specified needs of a
or improve current
analysis given data analysis
processes*

Formulates results of
Identifies data analyses, including Interprets results Generates hypotheses to predict
BIO 3.02. Data
pertinent to the information in the form within the context of future implications based on the
interpretation
analysis problem of graphs, charts, and the analysis problem evaluation of data analyses
tables

Uses data Evaluates


Selects visualization and Modifies existing visualization
BIO 3.03. Data visualization and representation and
representation tools for and representation tools to
visualization and representation tools visualization tools for
specified bioinformatics provide insight into
representation to present results of summarizing data
problems bioinformatics analyses
data analyses analyses

Discusses Contributes to new findings and


bioinformatics with Initiates bioinformatics Facilitates knowledge- meaningful advancements in
BIO 3.04.
other scientists collaborations with sharing with bioinformatics through the
Communication
within their colleagues stakeholders evaluation and sharing of
institution knowledge

BIO 4.00. Data management: conducts data management, storage, and retrieval

Subcompetency Beginner Competent Proficient Expert

Demonstrates basic Applies knowledge of Manipulates data


BIO 4.01. Data
knowledge of data data structures to structures to address Develops new data structures
structures*
structures relevant problems biological problems

Applies knowledge of
Describes data Evaluates data
BIO 4.02. Data data management Develops new data management
management management
management techniques to relevant techniques
techniques techniques
problems

BIO 4.03. Data Describes data Applies knowledge of Evaluates data storage
Develops new data storage and
storage and storage and retrieval data storage and and retrieval
retrieval techniques
retrieval techniques retrieval techniques techniques

BIO 4.04.
Describe available Manages allocation of
Allocation of Allocates computing Develops new methods for
computing resources multiple computing
computing resources allocation of computing resources
and capacity resources
resources

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* This term is defined in Appendix B.

TABLE 15. Public health laboratory competency guidelines: Research domain

RES 1.00. Research programs: develops research programs

Subcompetency Beginner Competent Proficient Expert

RES 1.01. Describes the Illustrates how research Formulates research projects Develops hypothesis-driven
Research laboratory's projects fit within the that align with the research objectives and a
objectives and research laboratory's research laboratory's research research agenda for the
agenda objectives objectives and agenda objectives and agenda laboratory

Describes general
funding Participates in writing Manages the overall
RES 1.02. Leads drafting of research
mechanisms that funding proposals for processes* for obtaining and
Research funding funding proposals
support public research projects sustaining research funds
health research

Reviews internal
RES 1.03. Describes basics proposals to verify
Serves as an ad hoc reviewer Serves on research proposal
Funding proposal of the proposal adherence to guidelines
for research proposal reviews review committees
reviews review process and recommended
principles

RES 1.04. Describes own


Recognizes research Participates in hiring Develops the strategic plan to
Research staffing role as part of the
staffing needs research staff recruit and retain researchers
needs research staff

Considers available
RES 1.05. Uses financial and Assesses financial, human, Aligns financial, human, and
financial, human, and
Research resource material resources and material resources when material resources to support
material resources when
management judiciously planning research projects the research program
planning experiments

Complies with Identifies Manages processes regarding Ensures that laboratory


RES 1.06. regulatory noncompliance with staff compliance with programs operate consistent
Regulatory requirements in regulatory requirements regulatory requirements with regulatory requirements
requirements* the performance pertaining to the concerning the performance concerning the performance of
of research performance of research of research research

TABLE 15. (Continued) Public health laboratory competency guidelines: Research domain

RES 2.00. Ethical conduct: ensures the ethical and responsible conduct of research

Subcompetency Beginner Competent Proficient Expert

Complies with Instructs others in Ensures staff


Oversees the policies, processes,
RES 2.01. Ethical policies,* processes, policies, processes, and compliance to policies
and procedures for implementing
conduct in and procedures* procedures regarding and procedures related
and maintaining ethical research
research* related to ethical ethical conduct in to ethical research
practices
conduct in research research practices

Complies with
Instructs others in Ensures staff Oversees the policies, processes,
policies, processes,
policies, processes, and compliance to policies and procedures for implementing
RES 2.02. Human and procedures
procedures related to and procedures related and maintaining ethical
and nonhuman related to doing
doing research in to doing research in practices* related to doing
subjects research in human
human and nonhuman human and nonhuman research in human and
and nonhuman
subjects subjects nonhuman subjects
subjects

RES 2.03. Complies with Describes complexities Ensures staff Builds research collaborations
Collaboration established regarding issues of compliance with
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agreements with collaboration, established


collaborators including authorship agreements for
research collaboration

Complies with
Ensures staff
established Describes issues that
compliance with
RES 2.04. Sharing agreements pertaining might arise pertaining Establishes guidelines for sharing
established
research data to research data to data ownership and research data
agreements regarding
sharing and the use of the sharing of data
data sharing
intellectual property

RES 3.00. Research foundation: integrates scientific and technical knowledge for use as a foundation for
research

Subcompetency Beginner Competent Proficient Expert

Performs basic Performs complex Validates


RES 3.01.
literature searches searches, aggregating appropriateness of Rectifies gaps in data generated
Literature
using a limited results from multiple how searches are from searches
searches
number of sources sources performed

RES 3.02.
Reads scientific and Assesses quality of Synthesizes scientific Evaluates scientific literature and
Critique of
technical literature literature and evidence derived from data to determine impact on
scientific
relevant to own work pertinence to own work literature laboratory research programs
literature

Applies appropriate
RES 3.03. Recognizes meaning Interprets statistical
statistical concepts and Critiques statistical tests and
Statistical of common statistical tests and concepts
tests in performance of concepts used in literature
concepts and tests concepts and tests used in literature
research

Considers study design


Explains Recognizes strengths Evaluates evidence-based
RES 3.04. Study characteristics when
characteristics of and limitations of study research guidelines to select or
designs planning research
common study designs designs develop study designs
activities

RES 3.05.
States scientific and Discusses scientific and Critiques scientific and Generates novel scientific and
Scientific and
technical concepts and technical concepts and technical concepts and technical concepts and
technical concepts
procedures procedures procedures procedures
and procedures

Identifies emerging
States latest scientific Discusses latest Analyzes emerging trends in
trends in scientific and
RES 3.06. and technical scientific and technical scientific and technical advances
technical advances and
Emerging trends advances relevant to advances relevant to to make decisions regarding
possible impact to
current research current research impact on laboratory
laboratory

TABLE 15. (Continued) Public health laboratory competency guidelines: Research domain

RES 4.00. Testing methodology development: develops new testing methodology

Subcompetency Beginner Competent Proficient Expert

States the
purpose of each
RES 4.01. New Oversees plans for the
step in existing Describes limitations of Proposes concepts for
testing development of new
testing existing methodologies improved methodologies
methodologies methodologies
methodologies
employed

RES 4.02. Pilot Contributes to Performs pilot testing, Designs strategies for Oversees pilot testing, method
testing, method pilot testing, method validation, or pilot testing, method validation, and performance
validation,* and method performance verification verification studies
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performance validation, or validation, or


verification* performance performance verification
verification

Participates in
RES 4.03. New Implements new Manages Oversees the implementation of
implementation
methodology methodologies into implementation of new new methodologies within the
of new
application laboratory practice methodologies laboratory
methodologies

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

Explains how own


Summarizes the public
RES 5.01. tasks and Oversees research projects to
health issues and research Designs research
Research project activities support address the identified public
questions addressed by projects
design specific research health issues or questions
specific research projects
projects

States the
RES 5.02. Generates the overall
purpose of each
Experimental Explains the overall Designs individual experimental strategy and
step performed in
strategy and experimental strategy experiments hypotheses for specific research
individual
design projects
experiments

RES 5.03. Uses established Provides input regarding Develops research


Oversees the conduct of
Conduct of research research protocols and the protocols to guide the
experiments
experiments protocols† conduct of experiments conduct of experiments

RES 6.00. Research data management, analysis, and application: conducts research according to
professional standards of data management, analysis, and application

Subcompetency Beginner Competent Proficient Expert

Records Designs data collection


RES 6.01. Data Monitors quality and Develops policies, processes, and
experimental and entry methods that
collection and integrity of recorded procedures to ensure data quality
procedures and meet data quality
quality* information and data and integrity
data standards

Complies with
Assists with the
RES 6.02. Data policies and Oversees the management of
management of data for Manages project data
management procedures for research data for the laboratory
individual experiments
data management

RES 6.03. Data Assists with data


Interprets data for Oversees data analysis plans and
analysis and analysis of
Analyzes project data individual research results interpretation for the
results individual
projects laboratory's research projects
interpretation experiments

Summarizes experimental Develops outlines and


RES 6.04. Data Describes data
data using multiple formats for data Critiques data summaries
summaries tables and graphs
formats summaries

RES 6.05. Examines the laboratory's Implements integration Oversees integration of internal
Application of States research data to determine of internal and external and external research findings
research findings laboratory's its significance in the research findings into into revised research agenda,
to current research findings context of the scientific laboratory's research objectives, and/or experimental
research literature practices strategies

TABLE 15. (Continued) Public health laboratory competency guidelines: Research domain

RES 7.00. Dissemination of research findings: disseminates research findings


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Subcompetency Beginner Competent Proficient Expert

Presents research
Attends Presents research to
RES 7.01. Meeting via oral
institutional colleagues within the Serves as an invited speaker at
and conference presentation for
scientific organization or via external meetings and conferences
presentations discipline-wide
presentations poster at external events
audiences

Publishes as first Publishes as senior author for multi-


RES 7.02. Assists in
Drafts sections of author or senior laboratory or multi-institutional
Manuscript manuscript drafting
research manuscripts author in journals research projects or in high-impact
preparation and editing
of the discipline interdisciplinary journals

Reads drafts of Participates in the


RES 7.03. Informally critiques Participates in the manuscript peer
manuscripts peer review process
Manuscript peer manuscripts submitted review process as member of the
submitted for peer as a formal
review process for peer review editorial board
review reviewer

RES 8.00. Translation: translates research findings to public health practice

Subcompetency Beginner Competent Proficient Expert

RES 8.01. States research


Directs translation
Translation of findings as they Describes implications Oversees translation of research
of research findings
research findings relate to current of research findings on discoveries into meaningful changes
to public health
into public health public health public health practices in public health practices
practices
practice practices

* This term is defined in Appendix B.


† A detailed plan for conducting a scientific procedure.

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Page last reviewed: May 15, 2015
Page last updated: May 15, 2015
Content source: Centers for Disease Control and Prevention

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