Guidelines for Biosafety Laboratory Competency

Guidelines for Biosafety Laboratory Competency
CDC and the Association of Public Health Laboratories
Supplements
April 15, 2011 / 60(02);1-6




Prepared by

Judy R. Delany, MS, MPH1

Michael A. Pentella, PhD2

Joyce A. Rodriguez, MS3

Kajari V. Shah, MS4

Karen P. Baxley5

David E. Holmes, PhD6
1Office of Surveillance, Epidemiology, and Laboratory Services, CDC

2University of Iowa, Iowa City, Iowa

3National Center for Environmental Health, CDC

4Association of Public Health Laboratories, Silver Spring, Maryland

5Office of Research Services, National Institutes of Health, Bethesda, Maryland

6Office of Safety, Health, and Environment, CDC



The material in this supplement originated in a multiagency, multisector workgroup that was sponsored by the Laboratory Science, Policy, and Practice Office, May Chu, PhD, Director, Office of Surveillance, Epidemiology and Laboratory Services, Stephen B. Thacker, MD, Director, and the Office of Safety, Health, and Environment, CDC, Paul J. Meechan, PhD, Director.

Corresponding preparer: Judy R. Delany, MS, MPH, Office of Surveillance, Epidemiology and Laboratory Services, CDC, 1600 Clifton Road., N.E., MS E-70, Atlanta, GA 30333. Telephone: 404-498-6488; Fax 404-498-6882; E-mail: jrd2@cdc.gov.



Summary
These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels (BSLs) (levels 2, 3, and 4). The competencies are tiered to a worker's experience at three levels: entry level, midlevel (experienced), and senior level (supervisory or managerial positions). These guidelines were developed on behalf of CDC and the Association of Public Health Laboratories (APHL) by an expert panel comprising 27 experts representing state and federal public health laboratories, private sector clinical and research laboratories, and academic centers. They were then reviewed by approximately 300 practitioners representing the relevant fields. The guidelines are intended for laboratorians working with hazardous biologic agents, obtained from either samples or specimens that are maintained and manipulated in clinical, environmental, public health, academic, and research laboratories.

Introduction
Biosafety laboratories must ensure adequate safety conditions to avoid potential hazards associated with the handling of biologic materials, the manipulation of genomes, the creation of synthetic organisms, and the spread of multidrug-resistant bacteria, and threats of biologic terrorism. These guidelines define the essential competencies needed by laboratory personnel to work safely with biologic materials and other hazards that might be found in a biologic laboratory (e.g., those related to research animals, chemicals, radiologic materials, and the physical environment).

A successful laboratory safety program encompasses a continuous process of hazard recognition, risk assessment, and hazard mitigation. The risk for exposures, laboratory-acquired infections, and the unintended release of research or clinical materials to the environment should ultimately be reduced by ensuring the competency of laboratorians at all levels.

Competencies are measurable and include not only knowledge, skills, and abilities but also judgment and self-criticism (1,2). The establishment of competencies is the essential first step in developing training. Although the 2006 Pandemic All-Hazards Preparedness Act (PAHPA) legislation required the development of competency-based training curricula (3), an extensive national and international library search identified no existing set of competencies for laboratory biosafety to guide this development. This gap spurred the effort to develop such a set of competencies.

Purpose
The primary purpose of these guidelines is to establish the behaviors and knowledge that laboratory workers at all levels should have to work safely with biologic materials. Other key issues addressed are the need for a well-designed workspace, knowledge of specific biologic agents and toxins, quality laboratory management practices, and an overall safety culture. This document provides essential competencies for incorporation into safety programs by laboratories that use biologic materials. These guidelines are designed for laboratorians practicing in the United States but also might have applicability for an international audience.

Background
Several circumstances led to the development of biosafety competencies for practicing laboratorians. In 2006, PAHPA called for the assessment, development, delivery, and evaluation of competency-based training for biosafety in high containment laboratories (3). In 2008, CDC convened the Blue Ribbon Panel for issues of Clinical Laboratory Safety to address incidence of laboratory-acquired infection (4). Also in 2008, a Trans-Federal Task Force (5) was convened for federal agencies with laboratories to address biosafety and biosecurity in working with agents that pose a significant public health threat, whether they arise from nature, accidental exposure, or deliberate terrorist attacks. These efforts underscored the need to develop competency guidelines for laboratory biosafety.

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Guidelines for Biosafety Laboratory Competency