Tech Environmental e-Newsletter
ARE YOU READY FOR USP 797? On January 1, 2008 the Joint Commission (JCAHO) will begin evaluating pharmacies and enforcing full compliance with USP 797. Is your hospital pharmacy prepared? What is USP 797? This is a far-reaching regulation developed by U.S. Pharmacopoeia that governs a wide range of environmental conditions and pharmacy procedures. Its goal is to protect both patients and workers from hazardous drugs and infectious agents. Can our pharmacy handle this on its own? Many of the current 797 requirements fall outside of the expertise and capabilities typically contained in even the largest and most sophisticated Pharmacy Departments. The support of Facilities, Engineering, Management, and Environmental Health and Safety is crucial.
What does USP 797 require? > Hazardous Drug Exposure Assessment: USP 797 requires semiannual surface wipe samples for hazardous drugs. Evaluation of exposure controls, such as Personnel Protective Equipment, safety training, and storage and waste handling. Wipe-testing and interpretation of the results must be performed by qualified professionals. > Ventilation: These assessments are an essential aspect of independent facility validation in both new and old facilities. Air flow direction, volume, exchange rates, monitors and alarms, air intake filtration efficiency, and room pressure differentials must be monitored through systems evaluation and tracked through associated documentation. > Total Particle Counts: Active electronic particulate monitoring will be required semi-annually, as well as during and after facility disruptions. The equipment to perform these measurements can be expensive, and must be operated by qualified personnel who can also interpret results. > Microbial Monitoring: Monthly active electronic air and surface sampling for microbial agents, in addition to weekly microbial monitoring of personnel, must be performed by experienced industrial hygienists and analyzed by qualified laboratories. > Program Development: Written site-specific programs, procedures and documentation for initial and ongoing activities are required. These will ensure that all aspects of USP 797 are met, while guaranteeing that the latest industry standards are being addressed on an ongoing basis as new methods and acceptance criteria are developed.
January 1st is eight months away. How seriously should I pursue USP 797 compliance right now? The basic criteria of USP 797 are the current industry standard, but the regulations are evolving as the deadline approaches. Pharmacies that begin preparing for 797 compliance today can ensure that they will be prepared for JCAHO monitoring and enforcement in 2008. It may also be helpful to enlist the assistance of an industrial hygiene professional who can keep abreast of the latest revisions to USP 797 and ensure compliance at all times. If you have questions and would like more information, please contact Dr. Thomas P. Fuller by email or by phone at (781) 890-2220 extension 112.
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STAFF SPOTLIGHT He has presented several invited papers on strategies to control pandemics and control of emerging infectious diseases. In June 2007 he will present a paper on Industrial Hygiene Activities in Hospital Infection Control at the annual AIHA meeting in Philadelphia. He is also part of a team preparing a display on pandemic influenza at that conference. Dr. Fuller received his Doctorate of Science in Industrial Hygiene from The University of Massachusetts Lowell, a Master of Science in Public Health from The University of North Carolina, and a B.S. in Allied Medical Professions from The Ohio State University. He specializes in safety program development and audits, and he has special expertise in finding sustainable solutions to complex environmental health and safety problems. ANESTHETIC GAS EXPOSURE HAZARDS
(OSHA) "Guidelines for Workplace Exposures to Anesthetic Gases" recommends that air sampling for anesthetic gases be conducted every 6 months to measure worker exposures and to check the effectiveness of control measures. A recent informal telephone survey of New England hospitals revealed that very few hospitals perform routine monitoring, and many cannot recall having completed surveys at all. Considering the potential health outcomes and the affects the gases could have on workers performing complex surgical tasks, routine monitoring is long overdue. In some cases, neglect could easily be construed as "non-compliance" with the OSHA General Duty Clause to protect workers from hazards. Dr. Tom Fuller is currently conducting anesthetic gas air monitoring in operating rooms and animal research labs for a university hospital in the Boston area, using a portable infrared detector and analyzer and passive diffusion dosimeters. These surveys are meant to identify system leakage, ambient levels for patient off-gassing in recovery rooms, and 8-hour occupational exposures. The results will be compared with regulatory levels and documented in a written report, along with any recommendations for improvement.
CONTACT US Waltham, Massachusetts 02451 ph. 781-890-2220 fax 781-890-9451
We are located at Reservoir Place on Trapelo Road off Exit 28, Rt. 128/I-95 in Waltham, Massachusetts.
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Exposure to nitrous oxide and other anesthetic gases has been associated with reduced fertility, spontaneous abortions, and neurological, renal, and liver disease. Exposure can also decrease mental performance, audiovisual acuity, and manual dexterity. The Occupational Safety and Health Administration 
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