Alphabet Soup for Infection Control Practitioners
A Guide to IC-Related Agencies
By Robert J. Sharbaugh, PhD, CIC
As infection control professionals (ICPs), we live in a world of acronyms, a veritable alphabet soup of regulating, accrediting and recommending agencies. This can be imposing, intimidating and downright confusing, especially to the new ICP. Nonetheless, these agencies have a direct impact on our professional lives. This article intends to unscramble the hodgepodge of terminology and provide insight into each of the agencies. The agencies can be classified as: regulatory, accrediting or recommending.
Occupational Safety and Health
Administration (OSHA) www.osha.gov
The Occupational Safety and Health Act was adopted by Congress in December 1970. Its purpose is "to assure safe and healthy working conditions for working men and women," which is the main crux of the OSHA General Duty Clause. It is important to understand that OSHA has no purview regarding patient care. Its sole intent is to protect the worker and its regulations should be interpreted solely on this basis. Four primary documents have been developed and promulgated by OSHA and have a direct impact on infection control practice.
- 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens; Final Rule; effective March 6, 1992.
- CPL 2-2.44D. Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens; effective November 5, 1999.
- 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Sharps Injuries; Final Rule. Amended and effective April 18, 2001.
- 29 CFR Part 1910.1035. Occupational Exposure to Tuberculosis; Proposed Rule; October 17, 1997.
There are 23 states and jurisdictions in the United States that have their own 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 be more so. It is important for ICPs to be aware of individual state plans that may impact their facility's policies and procedures relative to bloodborne pathogens and 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-site consultation services addressing safety and hygiene. Of special importance and significance is that such consultations involve no citations, no penalties and are strictly confidential. OSHA consultation services are completely separate from the compliance division; the results of any consultative finding or recommendations are not shared with other OSHA divisions. Specifics concerning individual state OSHA consultation services are available at osha.gov/oshprogs/consult.html
Food and Drug Administration (FDA) www.fda.gov
The 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) which has jurisdiction over such areas as food, drugs, medical devices, biologics, animal feed, cosmetics and radiation-emitting devices. Of particular use to ICPs would be the areas addressing food safety and medical devices. The FDA publishes a handbook of foodborne pathogens that lists such basics as signs and symptoms, diagnosis, infective dose and associated foods particular to a variety of foodborne pathogens. Such information has proved to be of great assistance in the preparation of in-service presentations relative to foodborne diseases. The handbook is titled "Bad Bug Book" and can be accessed at vm.cfsan.fda.gov/~mow/intro.html. Two additional Internet sites of particular interest to ICPs would be those addressing a complete list of all FDA cleared sterilants, their active ingredients and manufacturers (www.fda/gov/cdrh/ode/germlab.html) and detailed information relative to the August 2001 rule addressing the reuse of single-use devices (www.fda.gov/cdrh/reuse/index.shtml).
Environmental Protection Agency (EPA) www.epa.gov
There are two divisions in the EPA that have a direct bearing on infection control: the Office of Solid Waste and the Office of Pesticide Programs. 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 are listed. Information relative to the use of incinerators can also be found on this site. Access to the regulations of individual states involving medical waste 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 addresses pesticides and it is in this area that low- and intermediate-level liquid disinfectants are addressed (high-level disinfectants and sterilants are also listed but actually come under the control of the FDA). The EPA maintains a Web site containing a wealth of information relative to liquid disinfectants. EPA registered products are listed as belonging to one of four separate lists including those that are tuberculocidal (List B), effective vs. HIV (List C) and effective vs. both HIV and HBV (List D). Hyperlinks connect you to additional information such as manufacturers and contact individuals, EPA registration numbers, product formulation and ingredients.
Access to the National Antimicrobial Information Network can be obtained via ace.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 as the Healthcare Financing Administration (HCFA). Of particular significance to ICPs are the Conditions of Participation for Medicare/Medicaid as they would apply to acute care, long-term care and home care agencies. Access this Web site at 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.org
JCAHO is an independent, nonprofit, voluntary agency and is currently the primary accrediting agency for a variety of healthcare facilities providing acute care, long-term care, home care, behavioral health, assisted living and ambulatory care. Collectively, JCAHO accredits approximately 20,000 healthcare facilities, the majority of which are hospitals, long-term care facilities and home health agencies. The agency enjoys deemed status with CMS, which ensures JCAHO standards meet or exceed CMS requirements for Medicare certification. However, accreditation is not a requirement for Medicare or Medicaid reimbursement.
In addition to extensive and long-held standards for infection control programs, JCAHO enacted the ORYX initiative in 1997, which added a number of outcome objectives to the objectives necessary for accreditation. Presently, ORYX is applicable only to acute care, long-term care, home care and behavioral health facilities with data collection for hospitals scheduled to begin this month. The list of potential outcome objectives is quite large with a minimum of six such objectives being adopted for reporting purposes. Included are two specific measures relative to infection control: the occurrence of community acquired pneumonia and surgical site infections occurring within 30 days of surgery.
Community Health Accreditation Program (CHAP) www.chapinc.org
CHAP is an independent, nonprofit, voluntary agency. It enjoys deemed status with CMS and was the first accrediting agency to receive deemed status for accreditation of home care agencies.
Association for Advancement of Medical Instrumentation (AAMI)
AAMI was founded in 1967 and is a consensus organization consisting of manufacturers and users of medical devices. Within AAMI are several major committees, one of which is the Sterilization Standards Committee. It is this committee, with numerous working groups in its framework, that develops and publishes standards, recommended practices and technical information reports addressing all issues relative to decontamination and sterilization of patient care products. AAMI documents represent the accepted standards of care in the United States and are indispensable to operating room, central service and infection control personnel. Healthcare facilities are encouraged to maintain the latest editions of all AAMI documents pertinent to the provision of optimal patient care.
American Institute of Architects (AIA) www.e-architect.com
The AIA is responsible for establishing guidelines involving program, space and equipment needs for all clinical and support services in a healthcare facility. These guidelines represent the standard of care in the United States and are often referenced by the JCAHO as well as by various state and local health departments. AIA guidelines are updated every three to four years with the latest edition published in 2001. The guidelines address renovations and new construction with the 2001 edition, paying particular attention to ambulatory care, infection and biohazard control and long term and hospice care. Copies of the guidelines can be obtained by requesting Guidelines for Design and Construction of Hospital and Healthcare Facilities.
Agency for Healthcare Research and Quality (AHRQ) www.ahcpr.gov
The AHRQ, formerly the Agency for Healthcare Policy and Research, is a division of the HHS. The agency supports research to improve the quality of healthcare in a cost-effective manner. From 1992 to 1996, the AHRQ developed 19 clinical practice guidelines. Of these, several have direct bearing on infection control practices and include urinary incontinence in adults, prevention of pressure ulcers, pressure ulcer treatment and HIV infection. The guideline on pressure ulcer treatment points out the routine use of hydrogen peroxide, povidone iodine, iodophor and Dakin's solution in the day-to-day treatment of pressure ulcers is not recommended. Each guideline is available in the following versions:
- Clinical Practice Guideline presents recommendations for healthcare providers with brief supporting information, table and figures and pertinent references.
- Quick Reference Guide for Clinicians is a distilled version of the Clinical Practice Guideline, with summary points for reference on a daily basis.
- Consumer Version provides information for the general public to increase patient knowledge and involvement in healthcare decision making.
AHRQ Clinical Practice Guidelines are available electronically and via direct order through the AHRQ Publications Clearinghouse at (800) 358-9295.
Centers for Disease Control and Prevention (CDC) www.cdc.gov
The CDC is the most important recommending agency to those engaged in the practice of infection control and prevention. The CDC has facilities in 10 U.S. cities and consists of 11 divisions including four divisions that impact infection control practice:
- National Center for Infectious Diseases, including the Division of Healthcare Quality Promotion (DHQP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC)
- National Institute for Occupational Safety and Health (NIOSH)
- National Center for HIV, STD and TB Prevention
- Epidemiology Program Office
Division of Healthcare Quality Promotion (DHQP) www.cdc.gov/ncidod/hip/
DHQP, formerly the Hospital Infections Program (HIP), is responsible for the prevention of healthcare-associated infections/antimicrobial resistance, healthcare-related adverse events and medical errors. Services of DHQP which address these topics include, but are not limited to:
- Investigating and responding to outbreaks, emerging infections and adverse events
- Detecting, evaluating, monitoring and responding to emerging antimicrobial-resistant pathogens and infections
- Promoting patient and healthcare personnel safety
- Identifying, promoting and evaluating effective prevention interventions
The National Nosocomial Infection Surveillance System (NNIS) is an integral component of DHQP. NNIS was established in 1970 and is a cooperative effort between the CDC and participating hospitals to create a national nosocomial infections database. Participation in the NNIS System is voluntary and involves more than 300 acute care general hospitals in the United States. Long-term care facilities are not presently included in the NNIS System. The data from the NNIS System are reported annually in the November/December American Journal of Infection 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 Efficacy of Nosocomial Infection Control (SENIC) was a 10-year project, long since completed, that examined the efficacy of infection control programs.
Healthcare Infection Control Practices Advisory Committee (HICPAC) www.cdc.gov/ncidod/hip/HICPAC/Hicpac.htm
In 1991, Congress established the Hospital Infection Control Practices Advisory Committee (HICPAC), since renamed the Healthcare Infection Control Practices Advisory Committee. HICPAC is an advisory committee to the CDC. Members are selected by the secretary of HHS from experts in the field of infectious diseases, healthcare associated infections, nursing, epidemiology, public health and related areas of expertise. A primary function of HICPAC is to issue recommendations for preventing and controlling healthcare-associated infections in the form of guidelines, resolutions and informal communications. In addition to previously published HICPAC guidelines, there are at least six more that are scheduled for publication this year:
- Environmental control in healthcare facilities
- Sterilization and disinfection
- Isolation precautions in healthcare settings
- Hand hygiene
- Prevention of healthcare associated pneumonia
- Prevention of intravascular catheter-related infections
National Institute for Occupational Safety and Health (NIOSH) www.cdc.gov/niosh/about.html
A second major division within the CDC is NIOSH which, like OSHA, was established by the Occupational Safety and Health Act in 1970. NIOSH is responsible for conducting research and making recommendations for the prevention of work-related disease and injury. The agency is diverse, with employees representing industrial hygiene, nursing, epidemiology, engineering, medicine and statistics. Although NIOSH and OSHA were created by the same act of Congress, they are two distinct agencies with separate responsibilities. NIOSH is in HHS and is a research agency. OSHA is in the U.S. Department of Labor and is responsible for creating and enforcing workplace safety and health regulations. NIOSH and OSHA often work together to protect worker safety and health.
National Center for HIV, STD and TB Prevention www.cdc.gov/hiv/dhap.htm
A third major division within the CDC, the National Center for HIV, STD and TB Prevention, publishes two documents of considerable assistance to ICPs. The first is the HIV/AIDS Surveillance Report, published semiannually and procured free 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 is free 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 for healthcare professionals. It is intended as a reference manual for clinicians caring for persons with or at high risk for TB. It was designed to be useful in developing educational programs. In addition to the text document, a slide set is available.
Epidemiology Program Office www.cdc.gov/epo
A fourth major division of the CDC is the Epidemiology Program Office. The office publishes two major documents on a weekly basis: the Morbidity and Mortality Weekly Report (MMWR) and the MMWR Morbidity Tables. A free subscription 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 notifiable diseases, corresponding to the numbered tables printed in the back of the MMWR each week. This data is broken down by geographical region and provides up-to-date statistics relative to the number of cases of any specific reportable disease 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 infection control for Hill-Rom Company, Inc., in Charleston, S.C.