Document: Role of Clinical Laboratories in Bioterrorism Preparedness
Classification: Position Paper
Date: June 2002
Status: Approved by the ASCLS House of Delegates August 3, 2002

Introduction: A Historical Perspective

Biological weapons are the oldest of the nuclear, biological, and chemical triad of weapons of mass destruction. Recorded throughout history, references to the use of biologic agents scattered into embattled cities and populations to deliberately cause sickness and death can be traced back more than 2000 years. The discovery of biological warfare research programs in countries hostile to the United States have caused increased concern in the intelligence community over the past several decades. The capability to respond effectively to threats and to deal with the consequences of future attacks has become a major challenge and requires an immense national effort. Reductions in morbidity and mortality can be achieved by rapid medical response and early post attack medical intervention, all of which require organized planning, preparation, and training.

Background:

The clinical laboratory serves as a first line of surveillance of infectious disease agents and is responsible for the early detection and identification of the etiology of biologic agents. Clinical laboratories are staffed with practitioners who are skilled and perform these duties daily, whether the cause of the event is naturally occurring or terrorism. Clinical laboratories are critical players in planning strategies for early detection and prevention of further disease spread.

However, many clinical laboratories are limited in their level of preparedness. Although the first case of anthrax diagnosed in October 2001 was appropriately recognized locally in Florida and confirmed by the Florida State Public Health Laboratory, not all laboratories have staff specifically trained in bioterrorism (BT) agent recognition and referral. Some locations lack the appropriate facilities to safely work with BT agents, and others are simply unwilling to work with potential BT infected specimens.

A national system of laboratories, the Laboratory Response Network (LRN), has been established in response to bioterrorism preparedness planning. Clinical laboratories have access to this network, and local hospital and independent laboratories (Level A laboratories) will be expected to perform “rule out” procedures, and refer specimens to higher level laboratories (Level B, C or D laboratories) within the LRN. All clinical laboratories are encouraged to become part of the LRN structure to ensure they receive the proper training and awareness required to differentiate between contamination and a true BT event. Currently, only a small portion of the potential Level A labs have been identified and practitioners trained in Level A procedures for agents of bioterrorism.

The American Society for Clinical Laboratory Sciences (ASCLS) promotes collaborative efforts with government agencies and other professional scientific organizations in supporting clinical laboratories in their bioterrorism preparedness planning.

Role of Clinical Laboratories in Bioterrorism Preparedness

Position Statements:

ASCLS encourages the involvement of clinical laboratories at all levels of Bioterrorism Preparedness planning activities.
Achieving the level of preparedness necessary to protect the population requires the collective capabilities and resources of multiple federal, state, and local agencies, with the health care community. Clinical laboratories are an integral part of the health care community. ASCLS supports and encourages the active participation of clinical laboratories as one of the critical partners in BT planning efforts, maintaining effective communication and surveillance systems. Awareness and understanding of the role of clinical laboratory services and the expertise of their professional personnel is tantamount to a successful BT plan. Prevention and control strategies depend on the ability of the clinical laboratory to adequately provide and communicate critical information to public health and law enforcement agencies.

ASCLS supports the improvement of clinical laboratory capacity to identify, refer and report the recovery of potential biological warfare agents. Unlike a chemical terrorist attack, a biological attack may not be immediately apparent but appears insidiously. The clinical laboratory will likely be the first line of surveillance; the first to notice the recovery of unusual strains of organisms or unusual antimicrobial resistance patterns, the first to notice an increased number of isolated food-borne pathogens, or the first to recognize that an unusual outbreak of illness could be the result of a deliberate release of a biological agent. ASCLS encourages funding for clinical laboratories to improve their capacity, including technical expertise, adequate staff, improved instrumentation, sufficient supplies, and high speed internet access to provide timely communication.

ASCLS supports infrastructure improvement in clinical laboratories in order to control infection with communicable diseases. Overall preparedness for biological or chemical attack should include provisions for personal protective gear and decontamination procedures. The laboratory environment should include adequate space, engineering controls and appropriate work practices including biological safety cabinets, to minimize worker and public exposure to BT agents.

Clinical laboratories also need increases in financial support to recruit and retain qualified professionals to staff all shifts, so that trained personnel are available to perform Level A procedures at all times to identify a possible BT event.

ASCLS encourages clinical laboratories to employ only certified clinical laboratory professionals, capable of evaluating and analyzing microbiological data critical to proper assessment of a BT event, and to handle large increases in workload that may arise as a result of increased patient illness.
Clinical laboratory scientists, specialists, and appropriately supervised technicians who staff clinical microbiology laboratories must be able to determine whether an organism present is a potential pathogen, a contaminant, or a member of normal microbial flora. In the event of a biological attack, the clinical laboratory professionals will be expected to provide information on proper collection, processing, handling, or transport of samples to the appropriate laboratory. The acquisition of these decision-making skills requires appropriate education and preparation. ASCLS promotes certified clinical laboratory scientists, specialists and appropriately supervised technicians as qualified professionals who possess the necessary technical skills and experience to detect and identify biologic agents accurately and quickly. Qualified personnel ensure the timely identification of potential BT pathogens and initiation of therapy, thus decreasing the risk exposure and spread of the disease. All laboratories should have sufficient certified and experienced clinical laboratory scientists, specialists and technicians on staff to meet both routine and emergency needs.

ASCLS encourages the National Accrediting Agency for Clinical Laboratory Science (NAACLS) to ask clinical laboratory science education programs to include chemical, biological, nuclear, radioactive, and explosive exposures training in their curriculum. This training would allow the clinical laboratory workforce to have the appropriate knowledge base in the event of chemical or biological exposures.

In addition, financial incentives need to be provided to colleges and universities and clinical laboratory science education programs to encourage them to educate new clinical laboratory scientists to address the severe shortage of competent, prepared, and available professionals capable of recognizing a possible BT event.

ASCLS supports ongoing training of clinical laboratory practitioners in the management of biological warfare agents and bioterrorist threats. Continued training and development of technical skills of clinical laboratory practitioners in bioterrorism preparedness are crucial to ensure that practitioners possess the latest information on BT agents. In addition, competency and proficiency must be assessed and maintained. Training and education of the health care community, and specifically the laboratory community, requires a collaborative effort involving many major professional organizations. ASCLS supports the use of innovative delivery modules that may include but are not limited to:

• An interactive website to provide rapid dissemination of information
• Video streaming
• Distance learning or electronic series of technical materials
• Newsletters and other publications
• Roundtables, workshops and scientific sessions during local, state, regional and national meetings.

ASCLS supports and encourages partnerships among government research institutions, private industry and civilian clinical laboratories in research and development efforts.
The need to develop new tools for medical management and intervention of biologic threats is imperative. ASCLS supports increased research and development of improved and more rapid diagnostic and identification methods for biologic agents, new and better drugs for treatment or prophylaxis, and safer vaccines.