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LABORATORY GUIDELINES FOR ANALYSIS OF BIOTERRORISM SAMPLES
Citation:
Schaefer III, F W. LABORATORY GUIDELINES FOR ANALYSIS OF BIOTERRORISM SAMPLES. Presented at International Symposium on Waterborne Pathogens, Cascais, Lisbon, Portugal, September 22-25, 2002.
Impact/Purpose:
1) Refine new, practical methods for the detection of CCL-related and emerging waterborne human protozoa.
2) Perform field tests of devices or methods that have been developed under this task.
3) Evaluate these methods or devices in a variety of water matrices and parasite concentrations.
This work in this task supports CCL2 and 3 and is expected to be completed by 9/07.
Description:
After the attack on the World Trade Center on September 11, 2002, and the subsequent deaths associated with Bacillus anthracis spore contaminated mail, a worldwide need was apparent for increased laboratory capacity to safely analyze bioterrorism samples. The U.S. Department of Health and Human Services has furnished guidelines for microbiological and biomedical laboratory safety. These guidelines encompass laboratory practices and techniques, facility design, safety equipment, monitoring the analyst's health, vermin and insect control, as well as government control of select agents and specialized reagents.
Before work is initiated, the laboratory must have protocols which cover all standard operating procedures, quality assurance, chain of custody, and a detailed biosafety plan. Special emphasis is placed on the approach used in the event of either an accidental spill or accidental exposure. Extensive training in all aspects of the protocols is required for each analyst. Great care also is used to document both how and who processed the samples in case they have forensic significance.
Design of the laboratory facility centers around containment and segregation of the sample analyses, so as few people as possible are involved. Persons who are immunocompromised should not under any circumstances be permitted access to such a hazardous facility. Key card access through an airlock allowing only authorized personnel into the laboratory helps ensure such a policy. All laboratory benches must have impervious surfaces. The walls and floors also should be sealed, so liquids cannot penetrate them. The laboratory equipment and benches should be set up in a fashion to allow routine cleaning and disinfection. There must be a sink in each laboratory to facilitate hand washing. Interlocking double door autoclaves, a specialized negative pressure ventilation system, and waste stream treatment must all be part of the design.
The required safety equipment depends upon the type of analysis being performed. Generally gloves, laboratory coat or gown, shoe covers or boots, and eye protection are required. If the protocol entails analysis of a sample that is prone to the production of an aerosol, then a respirator is mandated. Most if not all procedures should be conducted in a biosafety cabinet. When centrifugations are necessary, they should be done with capped containers that in turn are placed in safety centrifuge cups. These cups are designed to prevent aerosols from being released during centrifugation. A biohazard warning sign naming the organism and incorporating the international biohazard symbol must be posted on all laboratory doors.
A key portion in the operations of any well managed laboratory is monitoring the health of the workers. Baseline and periodic serum samples should be collected and stored for future reference. Daily body temperature monitoring is encouraged. If available, vaccination should be offered. In addition, a treatment plan in case of exposure and/or infection is mandatory.
The ultimate responsibility for the safe operation of the laboratory falls to the director. He or she must establish policies and procedures that fully inform the analysts regarding all potential hazards. The director must review all protocols for scientific completeness and safety. Furthermore, the performance of each analyst must be reviewed and certified periodically. Use of independently prepared performance evaluation samples and external audits are strongly encouraged for this certification process. In the event a particular analyst does not meet the established criteria, then it is the director's responsibility to see corrective action is taken immediately. Moreover, the director must make sure all laboratory activities comply with federal and state regulations.