By Robert J. Sharbaugh, PhD, CIC
Asinfection control professionals (ICPs), we live in a world of acronyms, averitable alphabet soup of regulating, accrediting and recommending agencies.This can be imposing, intimidating and downright confusing, especially to thenew ICP. Nonetheless, these agencies have a direct impact on our professionallives. This article intends to unscramble the hodgepodge of terminology andprovide insight into each of the agencies. The agencies can be classified as:regulatory, accrediting or recommending.
Occupational Safety and Health
Administration (OSHA) www.osha.govThe Occupational Safety and Health Act was adopted by Congress in December1970. Its purpose is "to assure safe and healthy working conditions forworking men and women," which is the main crux of the OSHA General DutyClause. It is important to understand that OSHA has no purview regarding patientcare. Its sole intent is to protect the worker and its regulations should beinterpreted solely on this basis. Four primary documents have been developed andpromulgated by OSHA and have a direct impact on infection control practice.
There are 23 states and jurisdictions in the United States that have theirown state OSHA plans. These plans, however, must be approved by federal OSHA.They must be at least as restrictive as comparable federal standards, but may bemore so. It is important for ICPs to be aware of individual state plans that mayimpact their facility's policies and procedures relative to bloodborne pathogensand tuberculosis. Specifics concerning individual state plans are available at www.osha-slc.gov/fso/osp/index.html.
Upon request, the majority of state OSHA plans provides free, on-siteconsultation services addressing safety and hygiene. Of special importance andsignificance is that such consultations involve no citations, no penalties andare strictly confidential. OSHA consultation services are completely separatefrom the compliance division; the results of any consultative finding orrecommendations are not shared with other OSHA divisions. Specifics concerningindividual state OSHA consultation services are available at osha.gov/oshprogs/consult.html
Food and Drug Administration (FDA) www.fda.govThe FDA is under the U.S. Department of Health and Human Services (HHS).Within the FDA is the Center for Devices and Radiological Health (CDRH) whichhas jurisdiction over such areas as food, drugs, medical devices, biologics,animal feed, cosmetics and radiation-emitting devices. Of particular use to ICPswould be the areas addressing food safety and medical devices. The FDA publishesa handbook of foodborne pathogens that lists such basics as signs and symptoms,diagnosis, infective dose and associated foods particular to a variety offoodborne pathogens. Such information has proved to be of great assistance inthe preparation of in-service presentations relative to foodborne diseases. Thehandbook is titled "Bad Bug Book" and can be accessed atvm.cfsan.fda.gov/~mow/intro.html. Two additional Internet sites of particularinterest to ICPs would be those addressing a complete list of all FDA clearedsterilants, their active ingredients and manufacturers (www.fda/gov/cdrh/ode/germlab.html)and detailed information relative to the August 2001 rule addressing the reuseof single-use devices (www.fda.gov/cdrh/reuse/index.shtml).
Environmental Protection Agency (EPA) www.epa.govThere are two divisions in the EPA that have a direct bearing oninfection control: the Office of Solid Waste and the Office of PesticidePrograms. The Office of Solid Waste can be accessed at www.epa.gov/epaoswer/other/medical/index.htm,where the federal regulations governing the disposal of medical waste arelisted. Information relative to the use of incinerators can also be found onthis site. Access to the regulations of individual states involving medicalwaste and its disposal can be found at www.epa.gov/epaoswer/osw/stateweb.htm.
The Office of Pesticide Programs is a division of the EPA that addressespesticides and it is in this area that low- and intermediate-level liquiddisinfectants are addressed (high-level disinfectants and sterilants are alsolisted but actually come under the control of the FDA). The EPA maintains a Website containing a wealth of information relative to liquid disinfectants. EPAregistered products are listed as belonging to one of four separate listsincluding those that are tuberculocidal (List B), effective vs. HIV (List C) andeffective vs. both HIV and HBV (List D). Hyperlinks connect you to additionalinformation such as manufacturers and contact individuals, EPA registrationnumbers, product formulation and ingredients.
Access to the National Antimicrobial Information Network can be obtained viaace.orst.edu/info/nain.
Centers for Medicare and Medicaid Services (CMS) cms.hhs.gov
The last of the four major regulating agencies is the CMS, formerly known asthe Healthcare Financing Administration (HCFA). Of particular significance toICPs are the Conditions of Participation for Medicare/Medicaid as they wouldapply to acute care, long-term care and home care agencies. Access this Web siteat www.access.gpo.gov/nara/cfr/index.html.Once the site has been accessed, click on Title 42 Public Health, Oct.1, 2000,Parts 430 - 499.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO) www.jcaho.orgJCAHO is an independent, nonprofit, voluntary agency and is currentlythe primary accrediting agency for a variety of healthcare facilities providingacute care, long-term care, home care, behavioral health, assisted living andambulatory care. Collectively, JCAHO accredits approximately 20,000 healthcarefacilities, the majority of which are hospitals, long-term care facilities andhome health agencies. The agency enjoys deemed status with CMS, which ensuresJCAHO standards meet or exceed CMS requirements for Medicare certification.However, accreditation is not a requirement for Medicare or Medicaidreimbursement.
In addition to extensive and long-held standards for infection controlprograms, JCAHO enacted the ORYX initiative in 1997, which added a number ofoutcome objectives to the objectives necessary for accreditation. Presently,ORYX is applicable only to acute care, long-term care, home care and behavioralhealth facilities with data collection for hospitals scheduled to begin thismonth. The list of potential outcome objectives is quite large with a minimum ofsix such objectives being adopted for reporting purposes. Included are twospecific measures relative to infection control: the occurrence of communityacquired pneumonia and surgical site infections occurring within 30 days ofsurgery.
Community Health Accreditation Program (CHAP) www.chapinc.orgCHAP is an independent, nonprofit, voluntary agency. It enjoys deemedstatus with CMS and was the first accrediting agency to receive deemed statusfor accreditation of home care agencies.
Association for Advancement of Medical Instrumentation (AAMI)
www.aami.orgAAMI was founded in 1967 and is a consensus organization consisting ofmanufacturers and users of medical devices. Within AAMI are several majorcommittees, one of which is the Sterilization Standards Committee. It is thiscommittee, with numerous working groups in its framework, that develops andpublishes standards, recommended practices and technical information reportsaddressing all issues relative to decontamination and sterilization of patientcare products. AAMI documents represent the accepted standards of care in theUnited States and are indispensable to operating room, central service andinfection control personnel. Healthcare facilities are encouraged to maintainthe latest editions of all AAMI documents pertinent to the provision of optimalpatient care.
American Institute of Architects (AIA) www.e-architect.comThe AIA is responsible for establishing guidelines involving program,space and equipment needs for all clinical and support services in a healthcarefacility. These guidelines represent the standard of care in the United Statesand are often referenced by the JCAHO as well as by various state and localhealth departments. AIA guidelines are updated every three to four years withthe latest edition published in 2001. The guidelines address renovations and newconstruction with the 2001 edition, paying particular attention to ambulatorycare, infection and biohazard control and long term and hospice care. Copies ofthe guidelines can be obtained by requesting Guidelines for Design andConstruction of Hospital and Healthcare Facilities.
Agency for Healthcare Research and Quality (AHRQ) www.ahcpr.govThe AHRQ, formerly the Agency for Healthcare Policy and Research, is adivision of the HHS. The agency supports research to improve the quality ofhealthcare in a cost-effective manner. From 1992 to 1996, the AHRQ developed 19clinical practice guidelines. Of these, several have direct bearing on infectioncontrol practices and include urinary incontinence in adults, prevention ofpressure ulcers, pressure ulcer treatment and HIV infection. The guideline onpressure ulcer treatment points out the routine use of hydrogen peroxide,povidone iodine, iodophor and Dakin's solution in the day-to-day treatment ofpressure ulcers is not recommended. Each guideline is available in the followingversions:
AHRQ Clinical Practice Guidelines are available electronically and via directorder through the AHRQ Publications Clearinghouse at (800) 358-9295.
Centers for Disease Control and Prevention (CDC) www.cdc.govThe CDC is the most important recommending agency to those engaged inthe practice of infection control and prevention. The CDC has facilities in 10U.S. cities and consists of 11 divisions including four divisions that impactinfection control practice:
Division of Healthcare Quality Promotion (DHQP) www.cdc.gov/ncidod/hip/DHQP, formerly the Hospital Infections Program (HIP), is responsible forthe prevention of healthcare-associated infections/antimicrobial resistance,healthcare-related adverse events and medical errors. Services of DHQP whichaddress these topics include, but are not limited to:
The National Nosocomial Infection Surveillance System (NNIS) is an integralcomponent of DHQP. NNIS was established in 1970 and is a cooperative effortbetween the CDC and participating hospitals to create a national nosocomialinfections database. Participation in the NNIS System is voluntary and involvesmore than 300 acute care general hospitals in the United States. Long-term carefacilities are not presently included in the NNIS System. The data from the NNISSystem are reported annually in the November/December American Journal ofInfection Control and are also available at www.cdc.gov/ncidod/hip/surveill/nnis.htm.A second infection control program associated with HIP, a Study on the Efficacyof Nosocomial Infection Control (SENIC) was a 10-year project, long sincecompleted, that examined the efficacy of infection control programs.
Healthcare Infection Control Practices Advisory Committee (HICPAC) www.cdc.gov/ncidod/hip/HICPAC/Hicpac.htmIn 1991, Congress established the Hospital Infection Control PracticesAdvisory Committee (HICPAC), since renamed the Healthcare Infection ControlPractices Advisory Committee. HICPAC is an advisory committee to the CDC.Members are selected by the secretary of HHS from experts in the field ofinfectious diseases, healthcare associated infections, nursing, epidemiology,public health and related areas of expertise. A primary function of HICPAC is toissue recommendations for preventing and controlling healthcare-associatedinfections in the form of guidelines, resolutions and informal communications.In addition to previously published HICPAC guidelines, there are at least sixmore that are scheduled for publication this year:
National Institute for Occupational Safety and Health (NIOSH) www.cdc.gov/niosh/about.htmlA second major division within the CDC is NIOSH which, like OSHA, wasestablished by the Occupational Safety and Health Act in 1970. NIOSH isresponsible for conducting research and making recommendations for theprevention of work-related disease and injury. The agency is diverse, withemployees representing industrial hygiene, nursing, epidemiology, engineering,medicine and statistics. Although NIOSH and OSHA were created by the same act ofCongress, they are two distinct agencies with separate responsibilities. NIOSHis in HHS and is a research agency. OSHA is in the U.S. Department of Labor andis responsible for creating and enforcing workplace safety and healthregulations. NIOSH and OSHA often work together to protect worker safety andhealth.
National Center for HIV, STD and TB Prevention www.cdc.gov/hiv/dhap.htmA third major division within the CDC, the National Center for HIV, STD andTB Prevention, publishes two documents of considerable assistance to ICPs. Thefirst is the HIV/AIDS Surveillance Report, published semiannually and procuredfree of charge by calling (800) 458-5231 or electronically at www.cdc.gov/hiv/stats/hasr1102/cover.htm.The second is the Core Curriculum on Tuberculosis, 4th edition, 2000 that isfree and can be ordered by calling (404) 639-8135 or by visiting www.cdc.gov/nchstp/tb/pubs/corecurr/default.htm.This curriculum was designed to present basic information about TB forhealthcare professionals. It is intended as a reference manual for clinicianscaring for persons with or at high risk for TB. It was designed to be useful indeveloping educational programs. In addition to the text document, a slide setis available.
Epidemiology Program Office www.cdc.gov/epo|
A fourth major division of the CDC is the Epidemiology Program Office. Theoffice publishes two major documents on a weekly basis: the Morbidity andMortality Weekly Report (MMWR) and the MMWR Morbidity Tables. A freesubscription service to the MMWR can be accessed via www.cdc.gov/subscribe.html.Weekly editions and their contents can be accessed at www.cdc.gov/mmwr.The MMWR Morbidity Tables reflect provisional cases of selected notifiablediseases, corresponding to the numbered tables printed in the back of the MMWReach week. This data is broken down by geographical region and providesup-to-date statistics relative to the number of cases of any specific reportabledisease reported to the CDC. The tables can be viewed at wonder.cdc.gov/mmwr/mmwrmorb.asp.
Robert J. Sharbaugh, PhD, CIC, is the international director of infectioncontrol for Hill-Rom Company, Inc., in Charleston, S.C.