Appendix B

Terms Used in These Guidelines

Accounts receivable: the tracking of payments owed to the laboratory from the provision of goods and services, and the management of invoices generated for clients and other customers.

Accreditation: the process by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks.

Active listening: a communication technique in which a listener is attentive and empathetic, accepts the speaker's message without judgment, asks questions, and restates or paraphrases the speaker's message to get all the information needed to make a decision and to ensure full comprehension by both parties.

Administrative controls: measures concerning work procedures such as written safety policies, work practices, rules, supervision, schedules, and training with the goal of reducing the duration, frequency, and severity of exposures to hazardous materials or situations.

After Action Review (AAR): a structured activity or de-brief process for analyzing what happened, why it happened, and how it can be done better.

Agent-specific antigen detection: methods designed to test for specific antigens of microbial agents (e.g., bacteria, fungi, parasites, viruses) or for microbial antigen-specific antibodies. Testing might be performed using enzyme immunoassays (EIA) or immunofluorescent assays for direct detection of the antigen in a clinical sample or for identification of a given agent after it has been cultivated.

Alternative assessment: a system for determining the reliability of tests for which proficiency testing is either not available or not required. Appropriate alternative assessment procedures might include split-sample analysis with reference or other laboratories; split-sample analysis with an established in-house method; analysis using assayed materials or regional pools; clinical validation by chart review; or other suitable and documented means. Alternative assessment may also be considered performance testing.

Assessment: a systematic process of collecting and analyzing data to determine the current, historical, or projected condition of an organization, process, or activity; also referred to as inspection or survey.

Assessment rubric: a scoring tool that explicitly represents the performance expectations for an assignment or piece of work.

Assets: the resources of an organization or facility (e.g., staff, equipment, instruments, computers, materials including select agents and toxins, and controlled chemicals and other chemical materials).

Automated identification system: an automated, computerized system developed for the identification of bacteria and yeasts in clinical and nonclinical samples. Such systems can be semi-automated or fully automated. Examples include biochemical methods, nucleic acid amplification tests (NAAT), antimicrobial susceptibility testing panels, high-performance liquid chromatography (HPLC), and mass spectrometry.

Automated susceptibility testing system: an automated, computerized system developed for the detection of the sensitivity of organisms to one or more antimicrobial agents.

Basic scientific and laboratory concepts and theories: concepts and theories applied by staff during the performance of sample analyses. Examples include the effects of temperature on samples and organisms; the principles of acids, bases, and pH; molarity; accuracy and precision; sensitivity and specificity; the different wavelengths of light (and uses in the laboratory); the concepts behind different kinds of microscopy; the science behind distillation, filtration, extraction, and chromatography; and the principles of polymerase chain reaction (PCR), sequencing, enzyme-linked immunosorbent assay (ELISA) and other techniques.

Batch: a sequenced grouping of both test samples and all associated quality control samples required by a testing method.

Biohazardous materials: infectious agents or hazardous biological materials that present a risk or potential risk to the health of humans, animals, or the environment. The risk can be direct through infection or indirect through damage to the environment. Biohazardous materials include certain types of recombinant DNA; organisms and viruses infectious to humans, animals, or plants (e.g., parasites, viruses, bacteria, fungi, prions, and rickettsia); and biologically active agents (e.g., toxins, allergens, and venoms) that can cause disease in living organisms or cause significant impact to the environment or community.

Biological materials: any biologically derived materials or materials that contain biological species (e.g., microorganisms, genetically modified organisms or microorganisms, viruses, or prions). These materials are not necessarily pathogenic or hazardous. Examples include, but are not limited to, cellular lines, DNA materials, tissues, organs, body fluids, cultured cells, allergens, and select agents and toxins.

Biosecurity: the discipline addressing the security of biological agents and toxins and the threats posed to human and animal health, the environment, and the economy by misuse or release. It includes the protection of microbial agents, biological materials, and research-related information from unauthorized possession, loss, theft, misuse, diversion, or intentional release.

Budgeting: the process of developing plans for the laboratory's anticipated income and expenditures.

Capital budgeting: the process of planning funding for long-lived assets such as equipment and buildings.

Category A infectious substance: an infectious substance that is transported in a form that is capable of causing permanent disability or life-threatening or fatal disease to otherwise healthy humans or animals when exposure to the substance occurs. Examples include Bacillus anthracis (cultures only), Clostridium botulinum (cultures only), Hepatitis B virus (cultures only), West Nile virus (cultures only), and hemorrhagic fever-causing viruses such as the Ebola and Lassa viruses (in any form).

Category B infectious substance: an infectious substance not transported in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to the substance occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes. Examples include Vibrio cholera, Hepatitis A virus, Epsilon toxin of Clostridium perfringens, and food safety threats such as Salmonella species and Campylobacter jejuni.

Certification: a process by which a third party gives written assurance that a service or person conforms to specified requirements.

Chain of custody: procedures and the unbroken chain of documentation that account for the integrity of an item of evidence by tracking its movement, location, and possession from its point of collection to its final disposition.

Change control: 1) a structured method of revising any policy, process, or procedure; 2) a process for implementing changes to software or other information technology (IT) solutions using a coordinated approach.

Change management: a process to support moving from a current state through a transition state to a future state. From a process perspective, it is a structured method of revising any policy, process, or procedure (also referred to as Change Control). This includes activities such as transition planning and the design of hardware and software. It also includes revisions to all associated documents and records. From a personnel perspective, it is an approach to transitioning persons, teams, and organizations to a desired future state.

Chemical concepts: basic concepts and theories related to chemicals and their characteristics that staff should be able to apply in performing their job responsibilities. Examples include the principles of acids, bases, and pH; the theories underlying distillation, filtration, extraction, and chromatography; optical techniques; enzymes and rate analysis; principles of immunochemical techniques; principles of molecular biology; and the types of environmental media (e.g., water, soil, food, and animal feed) and the chemicals commonly found in each.

Chemical hygiene plan: a written program developed and implemented by the organization that outlines procedures, equipment, personal protective equipment, and work practices that are capable of protecting staff from the health hazards presented by hazardous chemicals used in that particular workplace and that complies with Occupational Safety and Health Administration (OSHA) regulations.

Chemical materials: substances with a distinct molecular composition that are produced by, or used in, chemical processes. Chemicals can be present in the laboratory as solids, liquids, mists, vapors, or gases.

Coaching: a specific behavior modification technique to improve another person's performance quantitatively and qualitatively.

Communication methods: methods that include in-person and virtual meetings, phone calls, and electronic methods (e.g., e-mail, social media, podcasts, and webinars).

Communication technology: the means by which information is exchanged between persons through the application of technical processes, methods, or knowledge (e.g., the use of e-mail, web-based presentations, or social media).

Computer science domains: subfields of computer science that can be directly applied to biological problems such as artificial intelligence, image processing, pattern recognition, data mining, knowledge representation, and natural language processing.

Confidentiality: a principle regarding the preservation of authorized restrictions on the access and disclosure of information, including means for protecting personal privacy and proprietary information. However, "confidentiality" is not synonymous with "privacy" (the right of a person to keep his or her information private).

Confidentiality, Integrity, and Availability (CIA): a compound term that refers to the following three elements:

• Confidentiality: preserving authorized restrictions on the access and disclosure of information, including means for protecting personal privacy and proprietary information;

• Integrity: guarding against improper information modification or destruction, and includes ensuring information nonrepudiation and authenticity;

• Availability: ensuring timely and reliable access to, and use of, information.

Continuity of Operations Plan (COOP): a strategic plan that details how essential functions of an agency will be handled during a wide range of emergencies or situations that might disrupt normal operations, including localized acts of nature, accidents, and technological or attack-related emergencies.

Continuous Quality Improvement (CQI): a recurring activity to increase the ability to fulfill quality requirements. CQI includes the actions taken throughout an organization to increase the effectiveness and efficiency of activities and processes in order to provide added benefits to the customer and organization.

Contract: a legally binding agreement between two parties for the purpose of obtaining goods or services. Contracts often contain specific obligations for both payor and recipient; and, there is usually significant programmatic involvement by the payor during the performance of the activities. Typically, dollars are drawn down as services defined in the agreement are performed.

Contractual instruments: documents that include Service Level Agreements (SLA), memoranda of understanding (MOU), memoranda of agreement (MOA), contracts with IT and other vendors, and data exchange agreements with data exchange partners.

Control measures: methods used to eliminate or reduce the potential for exposure to a hazard.

Corrective action: action that eliminates the cause(s) of a detected nonconforming event or other undesirable situation. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.

Cost of quality: the total of the tangible and intangible costs incurred by investing in the prevention of nonconforming events according to requirements, appraising a product or service for conformance to requirements, and reworking products or services to conform to requirements.

Critical surveillance event: a situation in which there is an active surveillance system for a specified reason and period usually initiating an urgent and highly-controlled systematic process. There is a significant need for use of staff and resources to support the determination of the agent at the center of the event.

Critical thinking: the thought processes used to conceptualize and evaluate information, and to the practice of using conclusions to guide individual and organizational behavior. Critical thinking involves clarifying goals, examining assumptions, discerning hidden values, evaluating evidence, and assessing conclusions.

Customer: an organization or person that receives a product or service. Examples include consumers, clients, end users, retailers, beneficiary purchasers, patients, and health-care providers. A customer can be internal or external to the organization. Laboratory staff may be regarded as internal customers.

Data structure: an organized form, such as an array list or string, in which connected data items are held in a computer.

Decontamination: the process of reducing or eliminating biologic, radioactive, or chemical agents from a surface or space. Decontamination includes disinfection and sterilization.

Diversity: the inclusion of different types of persons in a group or organization. Differing elements or qualities might include race, ethnicity, sex, sexual orientation, socioeconomic status, age, physical abilities, religious beliefs, political beliefs, or other ideologies.

Documents: paper-based or electronic media that communicate information. Generally, documents need to be updated periodically and require revision control.

eLearning: learning that utilizes electronic technologies to access training and educational curriculum outside of a traditional classroom. In many cases, it refers to a course, program or degree delivered completely online, though delivery can also include videotape, DVD, and interactive television.

Electronic laboratory reporting (ELR): the automated transmission of laboratory-related data from commercial, public health, hospital, and other laboratories to state and local public health departments through an electronic health records (EHR) system or a Laboratory Information Management System (LIMS).

Emergency alarm: a piece of equipment and/or device designed to inform staff that an emergency exists or to signal the presence of a hazard requiring urgent attention.

Emergency communication plan: a plan that is used during the response and recovery phases of an emergency or surge event to effectively and efficiently communicate with all staff internally and with emergency response personnel and the public externally.

Emergency preparedness and response networks: federal, state, and local networks that collaborate to provide emergency preparedness and response capabilities. Such networks include, but are not limited to, the National Incident Management System (NIMS) and the Integrated Consortium of Laboratory Networks (ICLN), which comprises the Laboratory Response Network for biological threats (LRN-B), the Laboratory Response Network for chemical threats (LRN-C), the Food Emergency Response Network (FERN), the National Animal Health Laboratory Network (NAHLN), the National Plant Diagnostic Network (NPDN), the Environmental Response Laboratory Network (ERLN), and the U.S. Department of Defense Laboratory Network (DLN).

Emergency response plan: a written plan that details step-by-step procedures to follow in emergencies such as fire, external chemical spills, or a major accident. An emergency response plan also includes information such as whom to notify, who should do what, and the location of emergency stocks.

Engineering controls: methods to remove a hazard or to place a protective barrier between the worker and the workplace hazard, which usually involves specialized equipment and elements of building design. Examples include safety equipment (e.g., biosafety cabinets), facility egress, and directional airflow.

Environmental controls: the conditions within a laboratory facility that accommodate the correct performance of laboratory testing. Examples of environmental controls are lighting, humidity, temperature, and floor space clearance.

Equal Employment Opportunity (EEO): policies and practices in employment and other areas that prohibit discrimination against an applicant or employee on the basis of race, color, sex (including pregnancy), age, religion, national origin, mental or physical disability, or genetic information.

Equipment qualification plan: a plan that addresses the three steps of laboratory equipment qualification (i.e., installation qualification, operational qualification, and performance qualification). Laboratory staff must perform the equipment performance qualification, and the equipment manufacturer may perform the installation qualification and operational qualification.

Ethical conduct in research: the application of rules and professional codes of conduct that promote the aims of research, encourage essential collaborations, ensure researchers are accountable and promote moral and social values. These principles include honesty in conducting and reporting research, objectivity, integrity, carefulness, openness, respect for intellectual property, confidentiality, responsible authorship and peer review, social responsibility, nondiscrimination, competence, legality, animal welfare, and protection of human subjects.

Ethical practices: values and standards such as personal accountability and credibility, honesty, fairness, forthrightness, striving for excellence, transparency, impartiality, respect for colleagues and partners, relationship building, diversity and inclusiveness, social responsibility, environmental responsibility, upholding privacy and confidentiality, and adhering to policies regarding conflict of interest.

Examination (analytical phase): a set of operations (analyses) having the objective of determining the value or characteristics of a property or sample, ending when the postexamination phase begins.

Exposure event: a specified set of conditions in which a person or group is subject to a harmful substance that is a potential cause of disease or an altered health state (e.g., a laboratory accident occurs causing workers to be exposed to radiation).

Exposure monitoring: a record of any measurements taken to monitor staff exposures and any medical consultation and examinations (including tests or written opinions).

Exposure prevention: a process that involves evaluating the incident response procedures to ensure that actions taken during the response do not result in hazardous exposures.

External assessment: a system to ensure compliance, competency, accuracy and precision of test system components, environment, and operator performance through evaluation by external groups or comparison using external samples. Examples include external audits and proficiency testing.

Federal Select Agent Program: a program that oversees the possession, use, and transfer of biological select agents and toxins. It comprises staff from CDC's Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service/Agricultural Select Agent Services.

Formative assessment: the gathering of information or data about a training course or program that is used to guide improvements in teaching and learning. Formative assessment takes place before the training implementation and includes such activities as pilot-testing.

Good housekeeping procedures; procedures related to the maintenance and management of the facilities, property, and equipment of an institution. Good housekeeping procedures prevent accidents and reduce the risk of harmful exposures to all laboratory and service staff.

Grant: a legally binding agreement between two parties usually for the purpose of transferring money, property, or services to a recipient, though it can also be used to procure products or services. Grants usually involve minimal programmatic involvement by the grantor. Typically, monies are given in a lump sum at the start of the agreement or according to a set disbursement schedule.

Hazardous chemical: any chemical which is classified as a health hazard or simple asphyxiant in accordance with the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard.

Hazard communication: a written program that conveys information concerning hazards. Hazard communication includes, but is not limited to, use of safety signage, Safety Data Sheets (SDS), and other written sources describing hazards of a material or space.

Hazard control: methods used to eliminate or reduce the potential for exposures to a hazard.

Hazardous material alert: an alert triggered by use of a hazardous material or safety equipment that requires either a notification (e.g., a label or signage) and/or a response (e.g., clean up or safety precaution).

Hazardous materials: solids, liquids, gases, or radioactive substances that can harm persons, other living organisms, property, or the environment.

Hazardous spill: a breach of a substance from its container (e.g., can, jar, drum, vessel, or pipe) in some fashion in the environment or community that results in exposure to high concentrations of toxic substances; situations that are life or injury threatening; imminent danger to life and health (IDLH) environments; situations that present an oxygen deficient atmosphere; conditions that pose fire or explosion hazards; situations that require evacuation of the area; and/or situations that require immediate attention because of the danger posed to persons in the area. The properties of the hazardous substance, the circumstances of the release, and the mitigating factors in the work area combine to define the distinction between a release requiring an emergency response and one that does not.

Incident: an unexpected event that causes or has the potential to cause loss, injury, illness, unsafe conditions, or disruptions to normal procedures.

Incident Command System (ICS): a standardized, on-scene, all-hazards incident management approach that allows for the integration of facilities, equipment, staff, procedures and communications that operate within a common organizational structure; enables a coordinated response among various jurisdictions and functional agencies, both public and private; and establishes common processes for planning and managing resources.

Incident response plan: a written program that identifies how staff should react to incidents and other emergencies at their facility.

Information: knowledge derived from study, experience, instruction, communication, intelligence, or news. It includes resources and materials that are created and distributed, including graphs or charts. Information also includes knowledge of specific events or situations that has been gathered or received.

Information security: the protection of information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide confidentiality, integrity, and availability (CIA). Information security measures include backup systems, passwords, and shredding of sensitive information before disposal.

Institutional safety committee: a group comprising a cross-section of staff members and other stakeholders with the goal of establishing or monitoring work practices to ensure worker safety, compliance, and awareness with regard to a specific or general workplace hazard. Examples include local committees such as the safety committee, radiation safety committee, institutional animal care and use committee, institutional review board, and environmental programs advisory panel.

Instructional design: the systematic development of instructional specifications using learning and instructional theory to maximize the quality of instruction, making the acquisition of knowledge and skill more efficient, effective, and appealing. Instructional design is the entire process of analysis of learning needs and goals and the development of a delivery system to meet those needs.

Integration engine is software that works as a go-between for different systems.

Internal audit: an activity carried out by laboratory staff that verifies laboratory operations adhere to the requirements of the management system, the customer, and/or regulatory agencies.

Inventory record: a record that tracks the quantity, form, location, and disposition of any biologic, chemical, or radiological material in use, stored, or disposed of in a laboratory.

Knowledge management (KM): the process of organizing, accessing, and leveraging a laboratory's intellectual resources and information systems to generate value-added benefits internal and external to the laboratory.

Laboratory-developed test (LDT): an in vitro device (IVD) that is intended for clinical use and designed, manufactured, and used within a single laboratory. LDTs are not approved or cleared by the U.S. Food and Drug Administration (FDA).

Laboratory equipment: the wide array of manual and automated machines (including instrumentation) used to perform sample preparation and analyses. This includes simple equipment (e.g., incubators, centrifuges, balances, water baths) and complex equipment (e.g., PCR machines, sequencers, mass spectrometers, multi-channel analyzers, ELISA readers).

Laboratory facility: the physical spaces within a public health laboratory building, including office spaces; meeting and conference rooms; areas where food is stored, prepared, or eaten; and areas where pre-examination, examination, and postexamination testing activities are performed. This also includes areas where laboratory supplies and reagents are stored, prepared, cleaned, and sterilized.

Laboratory Information Management System (LIMS): a collection of software/computerized methods that offers a set of critical features that support a laboratory's operations, including the acquisition, analysis, storage, and reporting of laboratory data. A LIMS is a highly configurable application that is customized to facilitate a wide variety of models for laboratory testing workflow. Sometimes referred to as LIS (Laboratory Information System).

Laboratory program: an organizational activity (e.g., quality assurance, safety, system improvement, training) or component that covers a major laboratory discipline (e.g., environmental chemistry, public health microbiology, newborn screening, environmental microbiology, molecular biology), which might include more than one laboratory section.

Learning environment: the physical and emotional states that the learner brings to the learning endeavor, as well as the social setting that the student finds in the learning space.

Legacy data system: an old or outmoded system being maintained because it contains historical data or other useful business intelligence.

Licensing: a documented approval process usually granted by governments (federal or state) to entities such as hospitals, laboratories, and persons to conduct a specific scope of activities within relevant jurisdictions.

Licensure: the official "permission to practice" for staff of defined occupations and professions. Licensure is often granted through a professional body or regulatory agency comprising advanced practitioners who oversee the applications for licenses. This often involves accredited training and examinations, but varies a great deal for different activities.

Lifecycle management strategy: the continuous process of managing the laboratory's IT investments and its procedures for testing, modifying, and implementing changes to existing computing systems, including hardware, software, documentation, and installing new systems throughout the lifecycle.

Logical structure: an introduction, supporting information, and conclusion.

Manual identification methods: various biochemical tests that are manually performed and used to identify bacteria, yeast and fungi. These tests may be performed either singly, such as spot tests or tube biochemicals (e.g., catalase, oxidase, indole, Triple Sugar Iron [TSI], or motility), or combined into multiple panels distributed commercially as strips or cards.

Manual susceptibility testing methods: various materials containing specific concentrations of antibiotics that are manually applied to media that has been plated with a specific concentration of an organism. The presence or absence of growth around the antibiotic disc or strip after incubation is measured and interpreted to determine the susceptibility of the organism to the antibiotic. Examples include the Kirby-Bauer method and Epsilometer test (E-test).

Master record: a record containing a comprehensive profile and other details about a person, material, or organization associated with the laboratory.

Medical surveillance program: the ongoing, systematic collection of health data that signal either biomarkers of exposure or early signs of adverse health outcomes from known biologic, chemical, and radiological materials and toxicants in persons working with those materials. This includes a program for pre-employment screening, ongoing monitoring, and postexposure management.

Memoranda of agreement (MOA): documents describing in detail the specific responsibilities of, and actions to be taken by, specific parties so that goals might be accomplished.

Memoranda of understanding (MOU): documents that describe broad concepts of mutual understanding, goals, and plans shared by parties.

Mentoring: a developmental partnership between a staff member and a subject matter expert for the purposes of sharing technical information, institutional knowledge, and insight with respect to a particular occupation, profession, organization, or endeavor. Typically, a mentor is a more experienced and knowledgeable person providing guidance to a mentee who is a less experienced and knowledgeable person.

Message type: the kind of a message communicated between systems that specifies its name, structure, and content data type.

Microbiological concepts and theories: concepts and theories that relate to characteristics of microorganisms and infectious agents that staff should be able to apply in performing their job responsibilities. Examples include taxonomy, pathogenic versus nonpathogenic microorganisms, incubation period, containment, principles of microbial culture, detection limits, antimicrobial susceptibility, and medium and mode of disease transmission.

Model laboratory practices: activities and processes integral to the provision of laboratory testing services that optimize the quality of the result. These practices are guided by certain industry standards and are adopted by a laboratory to maximize safety, effectiveness, efficiency, timeliness, and public health/community outcomes. These practices are usually independent of the test or measurement techniques employed and are not to be confused with U.S. Food and Drug Administration regulations on Good Laboratory Practice (FDA regulation 21 CFR 58). In the recent past, these practices were referred to as "best practices," but it is now acknowledged that there is not one collection of best practices for each laboratory or situation.

Module: a software component that is part of a larger enterprise software system and performs a specific, independent, and interchangeable function of the larger system.

Nonconforming event (NCE): an event that does not fulfill a requirement. Other terms frequently used include accident, adverse event, discrepancy, error, incident, nonconformity, and occurrence.

Notifiable result: a result generated by a laboratory from a sample related to an infectious disease or organism, hazardous agent, or condition that when identified by a laboratory, must be reported by the laboratory to specified public health entities as set forth under local, state, and/or federal law.

Occupational Safety and Health Administration (OSHA): the chief federal agency charged with the enforcement of safety and health legislation.

Outbreak: the occurrence of more cases of disease, injury, or other health condition than expected in a given area or among a specific group of persons during a specific period. Usually, the cases are presumed to have a common cause or to be related to one another in some way. Sometimes the cases are distinguished from an epidemic as being more localized.

Personal hygiene procedures: practices performed by persons that serve to promote or preserve health when working in the laboratory. Examples include washing hands after working with potentially hazardous materials and before leaving the laboratory; not eating, drinking, smoking, handling contact lenses, applying cosmetics, or storing food for human consumption in the laboratory; and not mouth pipetting.

Personal protective equipment (PPE): items worn by laboratory workers to prevent direct exposure to hazardous materials. Examples include gloves, gowns, aprons, laboratory coats, containment suits, shoe covers, eye and face shields, respirators, and masks.

Personnel security concepts: activities pursued in an attempt to evaluate a person's suitability for a given position. Typical personnel security concepts include verifying identity and personal information, professional information (e.g., previous employment and education), a person's character (e.g., through checking references), and a person's suitability for particular job responsibilities (e.g., through checking criminal records, court records, and credit reports).

Personnel security program: a system for addressing insider threats to ensure that only trusted persons are given authorized access to restricted areas. The program includes policies and procedures to ensure that persons that work within an organization are trustworthy and competent to carry out an organization's mission. This includes conducting interviews of applicants, evaluating positions, and verifying applicant suitability (e.g., through a National Agency Check with Inquiries [NACI] and special background investigations).

Physical hazards: unsafe conditions in the workplace that can cause injury or illness. Examples include ergonomic hazards; electrical shock hazards; loud noises; slip, trip, and fall hazards; exposure to hot and cold temperatures; compressed gas cylinders; and sharps (i.e., items capable of cutting or piercing human skin such as hypodermic needles, syringes [with or without attached needles], Pasteur pipettes, scalpel blades, suture needles, blood vials, needles with attached tubing, and culture dishes [regardless of the presence of infectious agents]; and other types of broken or unbroken glassware [e.g., microscope slides and cover slips]).

Physical security access controls: restrictions that provide reasonable assurance that only authorized staff are allowed to enter a restricted area. The type of access controls depends on the level of security required (e.g., something one has [such as a physical or electronic key], something one knows [such as a PIN number], or some natural/innate characteristic or trait [i.e., one that can be detected by biometric devices]).

Physical security infrastructure: the aggregate collection of physical elements, such as locks, access controls, alarms, closed-circuit television monitoring systems, fences and other barriers, sign-in logs, and security guards, designed to protect and safeguard the physical components of a facility, including staff and other assets.

Plain talk: nontechnical communication that does not use technical jargon or field-specific language. The speaker or writer conveys the meaning of the communication clearly and simply so that the information is easily understood. Also referred to as "plain language."

Policy: a set of basic principles or guidelines to direct plans, actions, and decisions of staff and the organization.

Postexamination (postanalytical phase): processes following examination (sample analysis) that include systematic review, formatting, and interpretation; authorization for release; and reporting and transmission of the results. This phase also includes storage of samples that have undergone laboratory analysis.

Pre-examination (pre-analytical phase): processes starting with, in chronological order, the submitter's test order and including: the examination (analysis) requisition; preparation of the patient (if applicable); collection of the primary sample; and transportation to and within the laboratory, ending when the examination (analytical) phase begins.

Preventive action: action that eliminates the cause(s) of a potential nonconforming event or any other potential undesirable situation. Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.

Procedure: a specified way to carry out an activity of a process.

Process: a set of interrelated or interacting activities to achieve a particular end.

Process improvement indicators: measures that track results and efficiencies gained in a laboratory following the modification of laboratory testing business processes.

Process management: activities that directly or indirectly relate to the laboratory's path of workflow to optimize effectiveness and efficiency.

Proficiency testing: an evaluation of the laboratory's performance on analysis of samples of external origin for the purposes of determining adequacy of the laboratory's pre-examination, examination, and postexamination activities.

Project management: the practice of planning and managing laboratory projects to ensure that they stay within scope, time, quality, and cost limits.

Project management concepts: principles regarding the management of projects that include controlling the process, meeting management, time management, scheduling, managing resources, and team building.

Protected information: any information about a person that is maintained by an organization that relates to issues of privacy (the right of a person to keep his or her information private) and confidentiality (ensuring that information is accessible only to those authorized to have access). Protected information includes any information that can be used to distinguish or trace a person's identity and any other personal, health, or medical information that is linked or linkable to a person. Notable regulations include the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, which governs the protection, use, and disclosure of individually identifiable health information, and the HIPAA Security Rule, which governs the security of certain health information that is held or transferred in electronic form.

Protocol: 1) a detailed plan for conducting a scientific procedure; 2) a set of technical rules for the transmission and receipt of information between computers.

Quality: the degree to which a set of inherent characteristics fulfills requirements.

Quality assessment: a means to determine the quality of the results generated by the laboratory. It is usually an external evaluation of the laboratory's performance. Quality assessment is a challenge to the effectiveness of the quality assurance and quality control programs and can be described as a system of procedures, checks, and audits to judge and control the quality of measurements and reduce the uncertainty of data.

Quality assurance (QA): planned and systematic activities implemented in a quality system so that quality requirements and goals for a product, service, or activity will be fulfilled. From a quality-improvement viewpoint, it is a system for ensuring a desired level of quality in the development, production, or delivery of products and services. From a bench-level viewpoint, it is the practice of assessing performance in all steps of the laboratory testing cycle including pre-analytical, analytical, and postanalytical phases to promote excellent outcomes in public health.

Quality control (QC): an integral component of quality assurance and is the aggregate of processes and techniques to detect, reduce, and correct deficiencies in an analytical process. It also refers to the measures that must be included during each assay to verify that a test is working properly.

Quality control (QC) data: QC measures intended to reflect the quality of laboratory testing processes and the accuracy, precision, and reliability of the test results.

Quality indicators: observations, statistics, or data defined by the organization or service that typify the performance of a given work process and provide evidence that the organization or service is meeting its quality intentions. Quality indicators are also referred to as "key performance indicators" or "quality metrics," and might be reported in various formats such as a "dashboard" or "scorecard."

Quality management system (QMS): coordinated activities to direct and control an organization with regard to quality. In a QMS, all aspects of the laboratory operation, including the organizational structure, processes and procedures, need to be addressed to ensure quality.

Radiation monitoring device: a scientific determination of amount, rate, and distribution of radiation emitted from a source of ionizing radiation. An example is a Geiger counter.

Radiological materials: radioisotopes, radioactive waste products, and chemical or biological materials that have been modified to include radioisotope labels.

Records: evidence of results achieved or activities performed. Records can be used, for example, to demonstrate traceability and to provide evidence of verification, preventive action, or corrective action. Generally, records need not be under revision control.

Reflex testing: follow-up testing when initial test results are positive or outside normal parameters and indicate that additional, related testing is clinically appropriate.

Regulated waste: liquid or semi-liquid blood or other potentially infectious materials, contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed, items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling, contaminated sharps, and pathological and microbiological wastes containing blood or other potentially infectious materials.

Requirement: a condition or capability needed to achieve an objective that must be met or possessed by a system or system component to satisfy a standard or specification.

Research animal: any live animal used or intended for use in research, research training, experimentation, biological testing or for related purposes. Examples include mice and rats. When evaluating hazards of research animals, staff should consider the risks inherent to the species itself, those associated with handling the animals (e.g., bites, scratches, and allergens), and the risks associated with handling the bedding and other associated waste products.

Risk assessment (risk analysis): 1) 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; 2) 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.

Risk communication: a style of communication used to exchange information and establish effective dialogue during emergency or highly sensitive situations by those responsible for assessing, minimizing, and regulating risk to those who might be affected by the outcomes of those risks.

Risk mitigation plan: an evaluation of threats, vulnerabilities, and consequences based on a site-specific risk assessment.

Root cause analysis: a process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a nonconforming event.

Route of exposure: the path by which humans or other living organisms come into contact with a hazardous substance. Examples include breathing (inhalation), eating or drinking (ingestion), and contact with skin (dermal absorption).

Safety Data Sheet (SDS): a fact sheet that summarizes: information regarding material identification for a chemical product or mixture, including hazardous ingredients; health, physical, and fire hazards and the necessary or suggested first aid procedures to employ; chemical reactivities and incompatibilities; spill, leak, and disposal procedures; and protective measures required for safe handling and storage.

Safety program: the general safety, biosafety, biosecurity, chemical, radiological, and emergency plans of an institution that all staff are required to follow in order to manage possible workplace hazards. The safety program also includes policies related to staffing, organizing safety committees, and conducting safety assessments.

Safety signage: a mechanism to communicate information related to hazards of a material or space. Examples include pictograms, container labels, and other posted signs.

Sample: a small part of, or a selection from, something intended to show the quality, style, or nature of the whole. In all domains of this competency set, "sample" is meant to include clinical and nonclinical samples and specimens.

Sample appropriateness: the physical, chemical, and biological characteristics of a sample that are necessary to yield accurate and representative test results.

Sample lifecycle: a comprehensive description of all sample processes, sample management, transfers, and data collection, with their corresponding LIMS actions throughout the period the laboratory interacts with the sample.

Sample management: the collection, handling, labeling, packaging, shipping, transport, accessioning, receipt, tracking, evaluation (including testing for sample appropriateness), and storage of clinical and nonclinical samples or specimens.

Scientific ethics: principles, rules, and standards guiding the performance of persons and the conduct of laboratory testing that include values and standards such as scientific credibility, scientific accountability, objectivity, assurance of scientific integrity, responsible collaboration, responsible authorship and peer review, adhering to intellectual property laws, and adhering to chain of custody rules and policies.

Scientific integrity: principles and standards such as validity, verification, and appropriateness. It also includes data integrity, by which information produced and results reported are whole, complete, and accurate; are obtained using proper methods; and are not altered by any unauthorized additions, deletions, or modifications.

Security concepts: aspects critical to the management of the security of an organization (including staff and other assets) and its activities. These concepts include assurance (that a security system will behave as expected), risks, threats, countermeasures, vulnerability, exploits, and defense in depth (relying on multiple security measures).

Security plan: a formal document that provides the systematic design for implementing an organization's security goals. It is a blueprint for how an organization secures its assets. It establishes the performance goals for the system and metrics for performance. Security plans are designed according to a site-specific risk assessment.

Segregated waste categorization: the procedures for categorizing, segregating, color-coding, storing, transporting, and tracking laboratory waste.

Select agents: a subset of biological agents and toxins that the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products. The Select Agent Regulations are contained in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331.

Sensitive information: privileged or proprietary information which, if compromised through alteration, corruption, loss, misuse, or unauthorized disclosure, could cause serious harm to the organization owning it. Sensitive information, which includes protected information, can only be released to the subject of the information and to those who have a legitimate need to know, to outside entities with the subject's written permission, and to others as allowed by law. In many cases, the use of this information is protected by either state or federal law.

Service level agreement (SLA): a contractual agreement between an internal or external service provider and the customer that specifies performance guarantees with associated penalties should the service not be performed as contracted.

Sharps: items capable of cutting or piercing human skin. Examples include hypodermic needles, syringes (with or without attached needles), Pasteur pipettes, scalpel blades, suture needles, blood vials, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). Also included are other types of broken or unbroken glassware (e.g., microscope slides and cover slips).

Software development life cycle (SDLC): a guideline for developing systems or software that involves progressive phases spanning the life cycle of the system from initiation to disposition.

Staff engagement: the heightened connection between staff and their work, their organization, or the persons for or with whom they work. Engaged staff find personal meaning in their work, take pride in what they do and where they do it, and believe that their organization values them.

Standard operating procedures (SOPs): established procedures to be followed in carrying out a given operation or in a given situation. Development of procedures is based on prudent laboratory practices that conform to safety guidelines and regulatory requirements.

Strain typing methods: methods to distinguish different strains of infectious agents. Examples include pulse-field gel electrophoresis (PFGE), multiple-locus variable number tandem repeat analysis (MLVA), and whole-genome sequencing (WGS).

Strategic thinking: a process by which a person develops a vision or goal and then works backward to develop a plan to accomplish that vision or goal.

Systems thinking: the set of habits or processes that permits a person to approach problems by visualizing and understanding interrelationships rather than linear-cause-effect chains, and by perceiving change as a series of on-going processes or events rather than as a single endpoint.

Training evaluation process: the gathering of information or data that takes place at the end of the training implementation or a specified period of time following training. It measures the effectiveness of the training (e.g., participant learning outcomes).

Training evaluation tools: methods that include assessment of skills and knowledge gaps, impact evaluation, return on investment, and participant reaction evaluation. It is usually an assessment tool administered to participants after the training activity to determine whether or not course design efforts were successful from the participants' perspectives.

Training modality: the delivery method used to provide training and education (e.g., in-person seminars, eLearning, web-based interaction, conferences, workshops, or teleconferences).

Training report: a document produced during the development of, and following, the delivery of a training activity. Reports might include training program evaluation summaries, attendance and continuing education credits awarded summaries, or statement of deliverables and outcomes realized through a training activity included in a funding reconciliation report.

Transportation security plan: a written security plan based on an assessment of possible transportation-related security risks for shipments of hazardous materials that includes appropriate measures to address these risks. The security plan should address staff security, unauthorized access, and en-route security.

Validation: the action (or process) of proving that a new procedure, process, test system, or method used works as expected and achieves the intended results. It includes determination of performance characteristics (i.e., accuracy, precision, sensitivity, specificity). Examples include validation of a new diagnostic assay or information system.

Verification: the ongoing process that confirms specified requirements (predetermined by validation) are fulfilled. Verification is needed when the laboratory replaces a test system or instrument; adds a new test; or changes the manufacturer of a test kit. The laboratory must verify the manufacturer's performance specifications are substantiated. An example includes the confirmation of results obtained on an automated testing analyzer of an assay approved by the U.S. Food and Drug Administration.

Vocabulary standard: vocabularies and systems of encoding data that have been defined by various standards development organizations. Reliance on these standards for terminology and coding of data greatly improves semantic understanding and, therefore, the value of the data in analyses and decision-making.

Waste management plan: a written set of procedures that describe decontamination practices and how the different waste streams (e.g., biologic, chemical, or radiological) generated in the laboratory will be handled to comply with regulatory and organizational requirements.

Work practices: actions performed by workers, such as decontaminating a work surface, with the goal of preventing or reducing the risk of exposure to hazardous materials or situations.

Workflow: 1) 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; 2) all of the tasks, in the proper order, required to carry out a process.

Project Governance Members

Project Manager: Catherine Johnson, MA, Association of Public Health Laboratories, Silver Spring, Maryland.

Facilitators: Mike Smith, PhD, Lead Facilitator, LuAnne Forrest, PhD, Kerrie Naylor, PhD, Janice Schonwetter, MS, Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Project Consultant: Kathleen Miner, PhD; Emory University, Rollins School of Public Health, Atlanta, Georgia.

Steering Committee: John M. DeBoy, DrPH,* Catherine Johnson, MA, Eva Perlman, MPH, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Judy R. Delany, MS, MPH,* Renée M. Ned-Sykes, PhD, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Wendi Kuhnert, PhD, National Center for Emerging and Zoonotic Infectious Diseases, Janet Nicholson, PhD,* Office of Infectious Diseases, Penney Reese, MS, Office of Public Health Preparedness and Response, CDC, Atlanta, Georgia.

Project Planning Workgroup Members

John M. DeBoy, DrPH,* Catherine Johnson, MA, Eva Perlman, MPH, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; LuAnne Forrest, PhD, Mike Smith, PhD, AlignOrg Solutions, Salt Lake City, Utah; Laura Gillim-Ross, PhD, Colorado Department of Public Health and Environment, Laboratory Services Division, Denver, Colorado; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Sara B. Imholte, MPH, Kathryn Wangsness, MHA, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Kathleen Miner, PhD, Emory University, Rollins School of Public Health, Atlanta, Georgia; Rick Panning, MBA, Fairview Health Services, Minneapolis, Minnesota; James Pearson, DrPH, Association of Public Health Laboratories, Silver Spring, Maryland; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts; Scott M. Shone, PhD, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Brenda Snodgrass, Oklahoma Department of Agriculture, Food and Forestry, Oklahoma City, Oklahoma; Michael Wichman, PhD, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Eddie Ades, PhD,* Melissa Olsen-Rasmussen, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Ann Berry, PhD, National Institute for Occupational Safety and Health, Judy R. Delany, MS, MPH,* Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Ritchard Parry, MS, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Susan Hunter, MS,* Wendi Kuhnert, PhD, Scott A. Sammons, MS, Angela Slaughter, National Center for Emerging and Zoonotic Infectious Diseases, Robert Kobelski, PhD, Tonia Parrott, PhD, National Center for Environmental Health, Janet Nicholson, PhD,* Office of Infectious Diseases, Penney Reese, MS, Office of Public Health Preparedness and Response, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia; Robert Lanciotti, PhD, National Institute for Occupational Safety and Health, CDC, Morgantown, West Virginia.

Competency Domain Team Members

Quality Management System

Team leads: Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Debra Kuehl, MS, Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Members: Jack Bennett, Connecticut Environmental Chemistry Laboratory, Rocky Hill, Connecticut; Jill Power, MS, New Hampshire Department of Health and Human Services, Public Health Laboratories, Concord, New Hampshire; Karen Stephani, New York State Department of Agriculture and Markets, Albany, New York; Tamara Theisen, Saginaw County Department of Public Health, Saginaw, Michigan; Xin Liu, PhD, Center for Global Health, CDC, Atlanta, Georgia.

Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Ethics

Team lead: Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Members: Catherine Johnson, MA, Association of Public Health Laboratories, Silver Spring, Maryland; Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Management and Leadership

Team leads: John M. DeBoy, DrPH, Association of Public Health Laboratories, Silver Spring, Maryland;* Rick Panning, MBA, Fairview Health Services, Minneapolis, Minnesota.

Members: Robyn Atkinson, PhD, Utah Public Health Laboratory, Taylorsville, Utah; Elizabeth Franko, DrPH, Georgia Public Health Laboratory, Decatur, Georgia; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Steve Gradus, PhD, City of Milwaukee Public Health Laboratory, Milwaukee, Wisconsin; Richard Harris, Wyoming Public Health Laboratory, Cheyenne, Wyoming; John Krueger, MS, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia.

Facilitator: Kerrie Naylor, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Communication

Team leads: Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Kathryn Wangsness, MHA, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Susan Hunter, MS, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.*

Members: Erin Bowles, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Tim Church, Washington Department of Health, Tumwater, Washington; Rick France, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida; Leslie McDonald, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Facilitator: LuAnne Forrest, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Security

Team leads: Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Kathleen Keyes, MS, National Center for Emerging and Zoonotic Infectious Diseases, Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Members: Jennifer Gaudioso, PhD, Sandia National Laboratories, Albuquerque, New Mexico; M. Kristy Osterhout, North Carolina State Laboratory of Public Health, Raleigh, North Carolina; Robert Rice, US Department of Agriculture, Animal and Plant Health Inspection Service, Washington, District of Columbia; Miki Van Houten, Oregon State Public Health Laboratory, Portland, Oregon; Paul Meechan, PhD, Office of Safety, Security and Asset Management, CDC, Atlanta, Georgia.

Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Emergency Management and Response

Team lead: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida.

Members: Christopher Chadwick, MS, Chris Mangal, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Christina Egan, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Bonnie Rubin, MLS, MBA, MHA, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Maureen Sullivan, MPH, Minnesota Department of Health, Public Health Laboratory, St. Paul, Minnesota; Victor Waddell, PhD, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Susan Hiers, MPH, National Center for Emerging and Zoonotic Infectious Diseases, Tonia Parrott, PhD, Rudolph Johnson, PhD, National Center for Environmental Health, CDC, Atlanta, Georgia.

Workforce Training

Team lead: La'Vonda Benbow, North Carolina State Laboratory of Public Health, Raleigh, North Carolina.

Members: Mary E. Hochstedler, Bonnie Rubin, MLS, MBA, MHA, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Valerie Johnson, MSPH, Ritchard Parry, MS, Center for Surveillance, Epidemiology, and Laboratory Services, Robert Kobelski, PhD, National Center for Environmental Health, CDC, Atlanta, Georgia.

Facilitator: LuAnne Forrest, PhD, AlignOrg Solutions, Salt Lake City, Utah.

General Laboratory Practice

Team lead: Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Members: Erin Bowles, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Patrick Dhooge, PhD, New Mexico Department of Health, Scientific Laboratory Division, Albuquerque, New Mexico; Douglas Haltmeier, MS, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Catherine Johnson, MA, Association of Public Health Laboratories, Silver Spring, Maryland; Martha Smith, MPA, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Debra Kuehl, MS, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Safety

Team leads: Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Kathleen Keyes, MS, National Center for Emerging and Zoonotic Infectious Diseases, Anne Pollock, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Members: Jennifer Gaudioso, PhD, Sandia National Laboratories, Albuquerque, New Mexico; M. Kristy Osterhout, North Carolina State Laboratory of Public Health, Raleigh, North Carolina; Robert Rice, US Department of Agriculture, Animal and Plant Health Inspection Service, Washington, District of Columbia; Miki Van Houten, Oregon State Public Health Laboratory, Portland, Oregon; Paul Meechan, PhD, Office of Safety, Security and Asset Management, CDC, Atlanta, Georgia.

Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Surveillance

Team leads: Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Kathryn Wangsness, MHA, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Susan Hunter, MS, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.*

Members: Diane Eckles, Arizona Department of Health Services, Office of Environmental Health, Phoenix, Arizona; Kirsten Larson, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Steve Marshall, MS, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Karen Anderson, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.

Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Informatics

Team leads: Cassandra Hadley, John Krueger, MS, Association of Public Health Laboratories, Silver Spring, Maryland.

Members: Willie Andrews, Virginia Department of General Services, Division of Consolidated Laboratory Services, Richmond, Virginia; Kakali Bandyopadhyay, PhD, Booz Allen Hamilton, Atlanta, Georgia; Mark Conde, Emory University, Rollins School of Public Health, Atlanta, Georgia; Paul Duffey, PhD, California Department of Public Health Laboratory, Moraga, California;* Reshma Kahhar, The St. John Group, Atlanta, Georgia; Garrett Peterson, MBA, Yahara Software, Madison, Wisconsin; Robert Sokolow, Association of Public Health Laboratories, Silver Spring, Maryland; Mary Kathryn Yost-Daljev, PhD, Virginia Department of General Services, Division of Consolidated Laboratory Services, Richmond, Virginia; Patricia Fields, PhD, National Center for Emerging and Zoonotic Infectious Diseases, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Facilitator: Janice Schonwetter, MS, AlignOrg Solutions, Salt Lake City, Utah.

Microbiology

Team leads: Kimberlee Musser, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts.

Members: Erin Bowles, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; John Barnes, PhD, Rebecca McNall, PhD, National Center for Immunization and Respiratory Diseases, Brandi Limbago, PhD, National Center for Emerging and Zoonotic Infectious Diseases, Melissa Olsen-Rasmussen, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia.

Facilitator: Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Chemistry

Team lead: Scott M. Shone, PhD, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey.

Members: Martin Bevan, Betsy Edhlund, PhD, Minnesota Department of Health, Public Health Laboratory, St. Paul, Minnesota; Patrick Dhooge, PhD, New Mexico Department of Health, Scientific Laboratory Division, Albuquerque, New Mexico; Douglas Haltmeier, MS, Martha Smith, MPA, New Jersey Department of Health, Public Health and Environmental Laboratories, Trenton, New Jersey; Jason Mihalic, Arizona Department of Health Services, Bureau of State Laboratory Services, Phoenix, Arizona; Michael Wichman, PhD, State Hygienic Laboratory, University of Iowa, Coralville, Iowa; Tonia Parrott, PhD, National Center for Environmental Health, CDC, Atlanta, Georgia; Robert Lanciotti, PhD, National Institute for Occupational Safety and Health, CDC, Morgantown, West Virginia.

Facilitator: Janice Schonwetter, MS, AlignOrg Solutions, Salt Lake City, Utah.

Bioinformatics

Team lead: Scott A. Sammons, MS, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.

Members: Ed Simpson, Indiana State Department of Health, Public Health Laboratory, Indianapolis, Indiana; William Wolfgang, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Duncan MacCannell, PhD, National Center for Emerging and Zoonotic Infectious Diseases, Elizabeth Neuhaus, PhD, National Center for Immunization and Respiratory Diseases, James Posey, PhD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, Georgia.

Facilitator: Janice Schonwetter, MS, AlignOrg Solutions, Salt Lake City, Utah.

Research

Team leads: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories – Tampa, Tampa, Florida; Laura Gillim-Ross, PhD, Colorado Department of Public Health and Environment, Laboratory Services Division, Denver, Colorado.

Members: Joanne Bartkus, PhD, Minnesota Department of Health, Public Health Laboratory, St. Paul, Minnesota; Peter Iwen, PhD, Nebraska Public Health Laboratory, University of Nebraska Medical Center, Omaha, Nebraska; Denise Kay, PhD, New York State Department of Health, Wadsworth Center, Albany, New York; Matthew Arduino, DrPH, National Center for Emerging and Zoonotic Infectious Diseases, Ruben Donis, PhD, National Center for Immunization and Respiratory Diseases, Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Facilitator: Kerrie Naylor, PhD, AlignOrg Solutions, Salt Lake City, Utah.

Workgroup Members

Development: John M. DeBoy, DrPH,* Catherine Johnson, MA, Eva Perlman, MPH, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; LuAnne Forrest, PhD, Kerrie Naylor, PhD, AlignOrg Solutions, Salt Lake City, Utah; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts; Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Synthesis: John M. DeBoy, DrPH,* Catherine Johnson, MA, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Mike Smith, PhD, Lorin Walker, PhD, AlignOrg Solutions, Salt Lake City, Utah; Judy R. Delany, MS, MPH,* Renée M. Ned-Sykes, PhD, Center for Surveillance, Epidemiology, and Laboratory Services, CDC, Atlanta, Georgia.

Adjudication Process: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida; John M. DeBoy, DrPH,* Catherine Johnson, MA, John Krueger, MS, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Michael Pentella, PhD, Massachusetts Department of Health, William A. Hinton State Laboratory Institute, Jamaica Plain, Massachusetts; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Kathleen Keyes, MS, Scott A. Sammons, MS, Leigh Vaughan, National Center for Emerging and Zoonotic Infectious Diseases, Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Patricia P. Wilkins, PhD, Center for Global Health, CDC, Atlanta, Georgia.

Harmonization of Domains: Andrew Cannons, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Tampa, Tampa, Florida; John M. DeBoy, DrPH,* Catherine Johnson, MA, John Krueger, MS, Pandora Ray, MA, MPH, Association of Public Health Laboratories, Silver Spring, Maryland; Leah D. Gillis, PhD, Florida Department of Health, Bureau of Public Health Laboratories–Miami, Miami, Florida; Susanne N. Zanto, MPH, Montana Department of Public Health and Human Services, Laboratory Services Bureau, Helena, Montana; Lia M. Haynes, PhD, National Center for Immunization and Respiratory Diseases, Debra Kuehl, MS, Renée M. Ned-Sykes, PhD, Anne Pollock, John C. Ridderhof, DrPH, Center for Surveillance, Epidemiology, and Laboratory Services, Leigh Vaughan, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia.