Agencies, Associations, and Organizations

The U�S� Code (U�S�C�) consists of a compilation of laws in force from 1789 to the present� As prima facie or presumed to be law, it does not include repealed or expired acts� The Federal Register (FR) publication system established on July 26, 1935, provides the official legal information service of the United States government� It functions under the authority of the Administrative Committee of the Federal Register (ACFR)� The FR operates through a statutory partnership with National Archives’ Office of the Federal Register (OFR) and the U�S� Government Printing Office (GPO)� The ACFR delegates its day-to-day authority to the Director of the OFR� The OFR administers programs under the Federal Register Act (44 U�S�C� Ch�15), the GPO Electronic Information Access Enhancement Act (44 U�S�C� 4101), the Freedom of Information Act (5 U�S�C� 551 et seq�), and other public information laws of the United States� The daily Federal Register posted on the GPO’s Federal Digital System serves as the official daily publication for rules, proposed rules, and notices of federal agencies and organizations, including executive orders and other Presidential documents�

The Code of Federal Regulations (CFR) serves as the codification source for the general and permanent rules published previously in the Federal Register. Users may access the CFR free of charge on the Federal Digital System maintained by the GPO� The CFR contains 50 titles with each title assigned to specific agencies that issue regulations pertaining to broad subject areas� The CFR permits the arrangement of official text of agency regulations or standards into a single publication� This provides a comprehensive and convenient reference for anyone needing to access federal general and permanent regulations� The CFR works with the FR, which provides updates on a daily basis to keep the CFR current� A full set of the CFR consists of approximately 200 volumes, with revision occurring annually on a quarterly basis as follows:

• Titles 1-16 as of January 1 • Titles 17-27 as of April 1 • Titles 28-41 as of July 1 • Titles 42-50 as of October 1

The Administrative Procedure Act was passed in 1945 (5 U�S�C� 551) and added several provisions to the FR system� The Act gave the public, in most instances, the right to participate in the rule-making process by commenting on proposed standards� Informing the public about proposed rule-making actions remains the primary purpose of the FR� Governmental agencies can promulgate standards using the administrative law process� Most federal agencies publish a regulatory agenda in the FR to inform the public of proposed or expected actions�

BOX 9.1 SELECTED CFR TITLES

• Title 10, Energy & Radiation (NRC) • Title 21, Food and Drugs (FDA)

(Continued)

The OSH Act and standards issued by the Occupational Safety and Health Administration (OSHA) apply to every private employer with one or more employees except those covered by other federal legislation� Under the Act, employers have the general duty of providing their workers a place of employment free from recognized hazards to safety and health, and must comply with OSHA standards� When OSHA compliance officers discover hazards, employers can receive citations listing alleged violations including proposed penalties and abatement periods� Employers may contest these before the independent Occupational Safety and Health Review Commission (OSHRC)� Employees must comply with standards and with job safety and health rules and regulations applying to their own conduct� Employees or their representatives have the right to file a complaint with OSHA requesting a workplace inspection� OSHA can withhold complainants’ names from the employer� Employees have the right, on request, to be advised of OSHA actions regarding their complaint� They also possess the right to an informal review to be made of any OSHA decision not to inspect a workplace� Employees also may attend the employer’s informal conference with OSHA to discuss any issues raised by inspection, citation, and notice of a proposed penalty or abatement period� In developing new or amended standards, OSHA invites full participation by employers and employees�

• 5(a)(1): Each employer must provide each employee a place of employment free from recognized hazards that could cause or likely cause death or serious physical harm to employees�

• 5(a)(2): Each employer must comply with occupational safety and health standards promulgated under the OSH Act�

• 5(b): Each employee must comply with occupational safety and health standards and rules, regulations, and orders issued pursuant to this Act as applicable to his or her actions and conduct�

Every workplace must display the OSHA Poster (Pub 3165), or the state plan equivalent� The poster explains worker rights to a safe workplace and how to file a complaint� Place the poster where employees will see it� You can order one free copy from OSHA or download a copy from the agency website at www�osha�gov� OSHA uses special criteria to conduct a programmed inspection� Criteria may include injury rates, death rates, exposure to toxic substances, or a high amount of lost

BOX 9.1 SELECTED CFR TITLES (Continued)

• Title 29, Labor (OSHA) • Title 40, Environmental Protection (EPA) • Title 42, Health and Human Services (NIOSH, CMS) • Title 44, Emergency Management (FEMA) • Title 49, Transportation (DOT)

BOX 9.2 TYPES OF OSHA STANDARDS

• General Industry Standards, 29 CFR 1910 • Standards for Shipyard Employment, 29 CFR 1915 • Marine Terminals Standards, 29 CFR 1917 • Long Shoring Standards, 29 CFR 1918 • Construction Standards, 29 CFR 1926

workdays for the industry� Another nonprogrammed inspection can occur when an employee makes a formal complaint to OSHA regarding a possible unsafe working condition or imminent danger at the workplace� If the inspector does not have a warrant, employers do not have to provide access to the facility under the Fourth Amendment� OSHA regulations require employers to report deaths on the job within eight hours� The agency then investigates the circumstances of the death, usually onsite, to determine the cause of death and if violations of the OSH Act occurred� If the agency determines that the employer failed to follow safety and health requirements, it issues citations and proposed civil penalties� OSHA bases proposed penalties on the statutory factors of employer size, gravity of violation, good faith of the employer, and the history of previous violations� OSHA penalties do not correspond to or reflect the value of a worker’s life or the cost of an injury or illness� OSHA instructs compliance officers to check the OSHA 300 Log and other documents to determine occupational health hazard trends� Inspectors can check healthcare facility safety records and Nuclear Regulatory Commission (NRC) radioisotope or radiation source licenses�

OSHA can refer a willful citation that resulted in a fatality to the Department of Justice for consideration for criminal prosecution� Any criminal prosecution by the Department of Justice does not impact OSHA authority to issue civil citations and penalties� OSHA can use criminal referral as an enforcement tool� However, most cases involving willful citations do not merit criminal prosecution�

Imminent danger situations receive top priority� An imminent danger refers to any condition with reasonable certainty that a danger exists that could cause immediate death or serious physical harm� If an imminent danger exists, the compliance officer will ask the employer to voluntarily abate the hazard and to remove endangered employees from exposure� Should the employer refuse, OSHA will apply to the nearest federal District Court for legal action to correct the situation� OSHA’s second priority involves investigation of fatalities and catastrophes resulting in hospitalization of three or more employees� Employees retain a right to request an OSHA inspection when placed in imminent danger from a hazard or whenever there is a violation of an OSHA standard that threatens physical harm� If the employee so requests, OSHA will withhold the employee’s name from the employer� OSHA establishes inspection priorities aimed at specific high hazard industries, occupations, or health hazards� Establishments cited for alleged serious violations may undergo a reinspection to determine whether the hazards are corrected� OSHA regulations require employers to report deaths on the job within eight hours� Employers may call their local office or the agency’s toll-free number of 800-321-6742� The agency investigates the circumstances of the death, usually onsite, to determine the cause of death and if violations of the OSH Act occurred� OSHA makes exceptions when the situation falls outside of the agency’s jurisdiction�

After the compliance officer reports the findings, the area director determines which citations warrant formal issuance and which penalties requirement assessment� An other than serious violation addresses issues that would not normally cause death or serious physical harm� OSHA can issue a serious violation if substantial probability exists that death or serious physical harm could result and the employer knew or should have known of the situation or hazard� OSHA cites imminent dangerous citations as serious violations� A willful violation refers to a situation that the employer intentionally and knowingly committed� The employer either knew that the operation constituted a violation, or was aware that a hazardous condition existed but made no reasonable effort to eliminate it� A repeat violation can address any standard, regulation, rule, or order where, upon reinspection, another violation of the previously cited section is found� Failure to correct any violations may bring civil penalties for every day the violation continues beyond the prescribed abatement date� Falsifying records, reports, or applications can bring a fine and/or six months in

jail upon conviction� Assaulting a compliance officer, or otherwise resisting, opposing, intimidating, or interfering with a compliance officer in the performance of his or her duties is a criminal offense�

States and jurisdictions can operate their own occupational safety and health plans with OSHA approval� State plans must establish standards that meet federal requirements� Approved state plans must extend their coverage to state and local government workers� Alliances enable organizations committed to workplace safety and health to collaborate with OSHA to prevent injuries and illnesses in the workplace� OSHA and its allies work together to reach out to, educate, and lead the nation’s employers and their employees in improving and advancing workplace safety and health�

Congress directed the Secretary of Labor through section 8(c)(2) of the OSH Act to prescribe regulations requiring employers to maintain accurate records and periodic reports on work-related deaths, injuries, and illnesses that do not involve medical treatment, loss of consciousness, restriction of work or motion, or transfer to another job� The Act requires OSHA to develop and maintain the effective collection, compilation, and analysis of occupational safety statistics� 29 CFR 1904, Recording and Reporting Occupational Injuries and Illnesses, requires employers to record information on the occurrence of injuries and illnesses in their workplaces� The employer must record work-related injuries and illnesses that meet one or more of published recording criteria� OSHA rules found in 29 CFR 1904 require all employers under OSHA jurisdiction with 11 or more employees to keep OSHA injury and illness records, unless the establishment is classified in a specific low-hazard retail, service, finance, insurance, or real estate industry� Employers with 10 or fewer employees must keep OSHA injury and illness records if OSHA or the Bureau of Labor Statistics informs them in writing that they must keep records under 29 CFR 1904�41�

The OSHA Log of Work-Related Injuries and Illnesses (Form 300) is used to document and classify workrelated injuries and illnesses� The Log also documents the extent and severity of each case� Employers use the Log to record specific details about what happened and how it happened� The Summary (Form 300A) shows totals for the year in each category� At the end of the year, post the Summary in a visible location to make employees aware of the injuries and illnesses occurring in the workplace� Employers must keep a Log for each establishment or site� If an employer operates more than one establishment, each location must keep a separate Log and Summary� Keep all logs for five years�

1. Medical Treatment Medical treatment includes managing and caring for a patient for the purpose of combating disease or disorder� Do not consider the following as medical treatments and do not record them: (1) visits to a doctor or healthcare professional solely for observation or counseling, (2) diagnostic procedures, including administering prescription medications used solely for diagnostic purposes, and (3) any procedure labeled as first aid�

2. Restricted Work Restricted work activity occurs when an employer or healthcare professional recommends that the worker can’t do the routine functions of his or her job for a full workday� Count the number of calendar days the employee was on restricted work activity or was away from work as a result of the recordable injury or illness� Do not count the day on which the injury or illness occurred in this

number� Begin counting days from the day after the incident occurs� If a single injury or illness involved both days away from work and days of restricted work activity, enter the total number of days for each� You may stop counting days of restricted work activity or days away from work once the total of either or the combination of both reaches 180 days�

3. Classifying Injuries An injury is a wound or damage to the body resulting from an event in the work environment� Examples include cuts, punctures, lacerations, abrasions, fractures, bruises, contusions, chipped teeth, amputations, insect bites, electrocution, or thermal, chemical, electrical, or radiation burns� Classify sprains and strain injuries to muscles, joints, and connective tissues as injuries when they result from a slip, trip, fall, or other similar accidents�

4. Classifying Illnesses OSHA considers skin diseases as illnesses caused by exposure to chemicals, plants, or other hazardous substances� OSHA defines respiratory conditions or illnesses as breathing-related problems associated with pneumonitis, pharyngitis, rhinitis, farmer’s lung, beryllium disease, tuberculosis, occupational asthma, reactive airways dysfunction syndrome, chronic obstructive pulmonary disease, and hypersensitivity� Examples can include heatstroke, hypothermia, decompression sickness, effects of ionizing radiation, exposure to ultraviolet rays, anthrax, and bloodborne pathogen diseases�

5. Posting the Summary Post the Summary, OSHA Form 300A, only (not the Log) by February 1 of the year following the year covered by the form� Keep it posted until April 30 of that year� Retain the Log and Summary for five years following the year to which they pertain� Do not send the completed forms to OSHA unless specifically asked to do so�

6. Form 301 Injury and Illness Incident Report Employers may use the OSHA 301 form or an equivalent form that documents the same information� Some state workers’ compensation, insurance, or other reports may be acceptable substitutes, as long as they provide the same information as the OSHA 301 form�

Employees potentially exposed to toxic substances or harmful physical agents in the workplace possess the right to access relevant exposure and medical records� Access includes current workers, former employees, and employees assigned or transferred to work involving toxic substances or harmful physical agents� Designated employee representatives may access employee medical or exposure records and analyses created from those records only in very specific circumstances� Designated employee representatives include any individual or organization employee with written authorization to exercise a right of access� Access gives the right to examine or copy medical and exposure records� Employees have the right to access records and analyses based on work concerns� Employers must permit access free of charge and within a reasonable period of time� Employees can access the material in one of three ways: (1) the employer may provide the employee a copy of the document, (2) the employer may provide facilities for employees to copy the document, or (3) the employer may loan a copy to the employee to copy offsite�

The EPA was created in 1970 to protect the environment and exercise control over release of harmful substances that could threaten public health� Many EPA rules define which substances can be hazardous to human health and/or pose a threat to the environment� The EPA or state-approved

agencies provide guidance for handling hazardous materials, regulate the operation of waste disposal sites, and establish procedures for dealing with environmental incidents such as leaks or spills� The EPA also has an interest in hazardous and infectious wastes produced by healthcare facilities� It publishes informative guides to assist risk managers in understanding and complying with a number of environmental laws and regulations� Environmental laws are published in 40 CFR�

The Resource Conservation and Recovery Act (RCRA) is one of the EPA’s main statutory weapons� The Act created a cradle-to-grave management system for current and future waste, while the EPA authorizes cleanup of released hazardous substances� Several statutes are media-specific and limit the amount of waste introduced into the air, waterways, oceans, and drinking water� Other statutes directly limit the production, rather than the release, of chemical substances and products that may contribute to the nation’s waste� The RCRA is unique in that its primary purpose is to protect human health and the environment from the dangers of hazardous waste� The RCRA has a regulatory focus and authorizes control over the management of wastes from the moment of generation until final disposal� The RCRA was passed in 1976 as an amendment to the Solid Waste Disposal Act� The general RCRA objectives are to (1) protect human health and the environment, (2) reduce waste and conserve natural resources and energy, and (3) reduce/eliminate generation of hazardous waste as expeditiously as possible�

The RCRA was amended in 1984 through passage of the Hazardous and Solid Waste Amendment� This action enabled the EPA to regulate underground storage tanks (USTs) to better control and prevent leaks� Title I of the RCRA regulated substances including petroleum products and CERCLA-regulated substances� Tanks with hazardous wastes are not regulated under Subtitle I but are regulated under Subtitle C of the RCRA� A UST has been defined as a container that has at least 10 percent of its contents underground� Facilities with underground tanks should take action to ensure piping does not fail, control corrosion of tanks and piping, and prevent spills and overflows� Refer to 40 CFR Part 280 for a listing of tanks excluded from the regulation�

This law intends to remedy the mistakes in past hazardous waste management, whereas the RCRA is concerned with avoiding such mistakes through proper management in the present and future� The RCRA mainly regulates how waste should be managed� The Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) authorized a number of

BOX 9.3 RCRA WASTE GENERATOR CLASSIFICATIONS

• Large quantity generators (over 1000 kg/month) • Small quantity generators (100 to 1000 kg/month) • Conditionally exempt generators (less than 100 kg/month) with no more than 1 kg acutely

hazardous waste

BOX 9.4 KEY RCRA REGULATORY GENERATOR REQUIREMENTS

• Identify and label all waste and notify the EPA of hazardous waste operations • Maintain secure storage areas, keep records, and train waste handlers • Use permitted treatment, storage, and disposal facilities

government actions to remedy the conditions or the effects of a release� CERCLA, as originally enacted in 1980, authorized a five-year program by the federal government to perform cleanup activities� CERCLA authorized the EPA to identify those sites where release of hazardous substances had occurred or might occur and posed a serious threat to human health, welfare, or the environment� The parties responsible for the releases were required to fund the cleanup actions�

During a five-year period, it became clear that the problem of abandoned hazardous waste sites was more extensive than originally determined� The Superfund Amendments and Reauthorization Act of 1986 (SARA) established new standards and schedules for site cleanup and also created new programs for informing the public of risks from hazardous substances in the community and for preparing communities for hazardous substance emergencies� Under Public Law 99-499, SARA specified new requirements for state and local governments� It also has provisions for the private sector related to hazardous chemicals� The Emergency Planning and Community Right-To-Know Act specifically requires states to establish a State Emergency Response Commission (SERC)� The SERC must designate emergency planning districts within the state� The SERC appoints a Local Emergency Planning Committee (LEPC) for each district� SERC and LEPC responsibilities include implementing various planning provisions of Title III and serve as points of contact for the community right-to-know reporting requirements� SARA Title III requires that the local committees must include, at a minimum, representatives from the following groups: state and local officials, law enforcement, civil defense, firefighting, environmental, hospital, media, first aid, health, transportation, and facility owners or operators subject to the emergency planning requirements�

The Clean Air Act (CAA) was passed to limit the emission of pollutants into the atmosphere; it protects human health and the environment from the effects of airborne pollution� The EPA established National Ambient Air Quality Standards (NAAQS, also known as KNACKS) for several substances� The KNACKS provide the public some protection from toxic air pollutants� Primary responsibility for meeting the requirements of the CAA rests with each state� States must submit plans for achieving KNACKS� Under Section 112 of the CAA, the EPA has the authority to designate hazardous air pollutants and set National Emission Standards for Hazardous Air Pollutants� Common air pollutants include the following: (1) ozone, (2) nitrogen dioxide, (3) carbon monoxide, (4) particulate matter, (5) sulfur dioxide, and (6) other sources including metal refineries, solvent usage, and manufacture of lead batteries� Air emissions from incinerators regulated by the RCRA must also comply with ambient air standards and emission limitations published under the provisions of the CAA� Extraction of pollutants from air emissions under CAA control using equipment such as scrubbers can create hazardous waste or sludge containing such waste� Disposal of incinerator materials must also comply with the RCRA�

The Clean Water Act (CWA) of 1977 strengthened and renamed the Federal Water Pollution Control Act of 1972� The Act has several major provisions, including the establishment of the National Pollutant Discharge Elimination Systems (NPDES) Permit Program to permit discharges into the nation’s waterways� Any direct discharges into surface water requires a NPDES permit� An indirect discharge means that the waste is first sent to a publicly owned treatment works and then discharged pursuant to a permit� Sludge resulting from wastewater treatment should be handled as RCRA waste and disposed of at an RCRA facility if deemed hazardous� The act requires that certain industrial and municipal storm water discharges be regulated under the NPDES permit system�

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was passed in 1947 and was initially administered by the U�S� Department of Agriculture (USDA)� The EPA became responsible for the Act in 1970� A 1972 amendment included provisions to protect public health and the environment� FIFRA controls risks of pesticides through a registration system� No new pesticide can be marketed until it is registered with the EPA� The EPA can refuse to register a pesticide or to limit use if evidence indicates a threat to humans and the environment� All pesticides and general disinfectants used in healthcare facilities should be approved and registered by the EPA�

The Toxic Substances Control Act (TSCA) was enacted in 1976 to help control the risk of substances not regulated as drugs, food additives, cosmetics, or pesticides� Under this law, the EPA can regulate the manufacture, use, and distribution of chemical substances� The TSCA mandates that the EPA be notified prior to the manufacture of any new chemical substance� The EPA ensures that all chemicals are tested to determine risks to humans� The TSCA also allows the EPA to regulate polychlorinated biphenyls (PCBs) under 40 CFR 761�

This independent agency, established by the Energy Reorganization Act of 1974, regulates civilian use of nuclear materials� NRC employs a staff of 3000 with two-thirds of the employees working at the Rockville, Maryland headquarters location� NRC staffs four regional offices and assigns resident inspector offices at each commercial nuclear power plant and some fuel cycle locations� Headed by a five-member commission, the NRC regulates byproduct, source, and special nuclear materials to ensure adequate public health and safety, common defense and security, and protection of the environment� The NRC adopts and enforces standards for the departments of nuclear medicine in healthcare facilities� Some states have agreements with the government to assume these regulatory responsibilities� NRC issues five-year licenses to qualified healthcare organizations that follow prescribed safety precautions and standards� Types of regulated facilities include (1) nuclear power plants, (2) departments of nuclear medicine at hospitals, (3) academic activities at educational institutions, (4) research work in scientific organizations, and (5) industrial applications such as gauges and testing equipment�

The National Institute for Occupational Safety and Health (NIOSH) conducts research and makes recommendations that help prevent work-related injury and illness� NIOSH, established by the OSH Act of 1970, operates under the administrative control of the Centers for Disease Control and Prevention (CDC)� Although NIOSH and OSHA were created by the same Act of Congress, they operate as distinct agencies with separate responsibilities� However, NIOSH and OSHA often work together toward the common goal of protecting worker safety and health� NIOSH publishes educational resources and guidelines on a number of healthcare-and hospital-related topics�

The CDC, located in Atlanta, Georgia, is an agency of the Department of Health and Human Services (DHHS)� It works to protect the health of the American people by tracking, monitoring, preventing, and researching disease� It is also responsible for surveillance and investigation of infectious disease in healthcare facilities� The CDC conducts research and publishes results in

its Morbidity and Mortality Weekly Report� This weekly publication provides healthcare facilities with timely information on topics such as infection control, isolation procedures, bloodborne pathogens, tuberculosis management, infectious waste disposal recommendations, and how to protect workers� CDC performs many of the administrative functions for the Agency for Toxic Substances and Disease Registry (ATSDR), a sister agency of the CDC, and is one of eight federal public health agencies within the DHHS� CDC seeks to accomplish its mission by working with partners throughout the nation and world to monitor health, detect and investigate health problems, conduct research to enhance prevention, develop and advocate sound public health policies, implement prevention strategies, promote healthy behaviors, foster safe and healthful environments, and provide leadership and training� CDC develops and sustains many vital partnerships with public and private entities that improve service to the American people�

The FDA, created by the Appropriation Act of 1931, operates under the auspices of the DHHS� The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation� FDA advances public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health� The FDA possesses the responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors� It plays a significant role in the nation’s counterterrorism capability� The FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats� It ensures the safety of food, human and veterinary drugs, biological products, medical devices, cosmetics, and any electronic products that emit radiation, and oversees biologic product manufacturing and the safety of the nation’s blood supply� The FDA also conducts research to establish product standards and develop improved testing methods� It sets standards for drug approvals and over-the-counter and prescription drug labeling/manufacturing standards� The FDA also oversees the labeling and safety of all food products (except meat and poultry) and bottled water� It grants premarket approval of new devices, establishes manufacturing and performance standards, and tracks device malfunctioning and serious adverse reaction events� The FDA develops radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems, laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps� The FDA also accredits and inspects mammography facilities� In 2007, the President signed into law the Food and Drug Administration Amendments Act� The revised law represented a very significant addition to FDA authority� Among the many components of the law are the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA)�

The Agency for Healthcare Research and Quality (AHRQ) serves as the health services research arm of the Department of Health and Human Services� It provides a major source of funding and technical assistance for health services research and research training at leading universities and other institutions� The Agency is a science partner, working with the public and private sectors to build the knowledge base for what works and does not work in health and healthcare and to translate this knowledge into everyday practice and policymaking� Health services research examines how people get access to healthcare, how much care costs, and what happens to patients as a result of this care� The main goals of health services research include identifying the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve

patient safety� The Agency’s research findings help practitioners diagnose and treat patients more effectively� A computerized clinical information system developed with the Agency’s support now helps healthcare professionals determine the most appropriate timing for giving antibiotics to surgical patients� A national clearinghouse gives clinicians, health plans, and healthcare delivery systems a web-based mechanism for obtaining detailed objectives on clinical practice� The Agency complements the biomedical research mission of its sister agency, the National Institutes of Health (NIH)�

NIH operates 27 centers and serves as one of the world’s foremost medical research organizations� It pursues fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability� NIH supports the health of the nation by conducting and supporting health related research� It places an emphasis on developing, maintaining, and renewing scientific evidence that will improve the nation’s capability to prevent disease�

The Centers for Medicare & Medicaid Services (CMS) operates 10 field offices that were reorganized in February 2007� The agency moved from a geography-based structure to consortia with key responsibilities focusing on survey and quality improvement� The agency also publishes guidelines governing long-term nursing facilities� The guidelines emphasize resident’s rights and quality of care� The Omnibus Budget Reconciliation Act (OBRA) of 1987 gave the CMS the power to regulate facilities receiving federal funds� The Medicare Modernization Act or MMA became law in December 2003 and added outpatient prescription drug benefits to Medicare�

The Institute of Medicine (IOM) serves as an adviser to the nation for health improvement� As an independent, scientific adviser, the IOM strives to provide advice that is unbiased, based on evidence, and grounded in science� The mission of the IOM embraces the health of people everywhere� The Institute is a part of the National Academies and provides science-based advice on matters of biomedical science, medicine, and health� It is a nonprofit organization that provides a vital service by working outside the framework of government to ensure scientifically informed analysis and independent guidance� The Institute provides evidence-based and authoritative information/advice concerning health and science to policymakers, professionals, and leaders in every sector of society� Committees of volunteer scientists serve without compensation� Each report produced by committees goes through a review and evaluation process� The review is conducted by a panel of experts that remain unknown to the committee� The Institute’s work centers principally on committee reports or studies on subjects ranging from quality of medical care to medical errors� The majority of the studies and other activities receive funds from the federal government� Other studies can be initiated by private industry, foundations, state or local governments, and the Institute�

The most well known of the accrediting bodies, the Joint Commission, impacts the operation of most hospitals and a good number of other healthcare organizations, including nursing homes and surgery centers� The Joint Commission operates as an independent, not-for-profit organization,

governed by a board that includes physicians, nurses, and consumers� The mission to continuously improve safety and quality care through accreditation supports performance improvement in healthcare organizations� The Joint Commission sets the standards to measure many aspects of patient care and quality� To maintain and earn accreditation, a healthcare organization must undergo an extensive onsite review by a team of surveyors, at least once every three years� The review helps evaluate the organization’s performance in areas that affect patient care� Organizations should provide a safe, functional, supportive, and effective environment for patients, staff, visitors, and contractors� Effective safety management provides guidance to achieve quality patient care, good outcomes, and continuous improvement� Some key environment and care requirements include long range and continuous planning by organizational leaders to ensure space requirements, proper equipment, and necessary resources remain available to support services offered� The planning and design of the environment should be consistent with the organizational mission to support proper care considering the patient’s physical condition/health, cultural background, age, and cognitive abilities� Organizations should educate staff on their roles in the environment of care in safely, sensitively, and effectively supporting patient care� Organizations should also educate staff on physical requirements processes for monitoring, maintaining, and reporting on the organization’s environment of care� Other requirements include developing standards to measure staff and organizational performance in managing and improving the environment of care and establishing an effective Information Collection and Evaluation System (ICES)� Environment and care standards do not prescribe any particular safety-related structure� The standards don’t address the specific type of safety committee or a specific individual to serve as safety officer� An organization with multiple sites may develop separate management plans for each location or choose to use a single comprehensive set of plans� The organization should address specific risks and unique conditions at each site� The six functional areas addressed in EOC management plans include: (1) Safety Management, (2) Security Management, (3) Fire Safety Management, (4) Hazardous Materials and Waste Management, (5) Medical Equipment Management, and (6) Utilities Management� Emergency Management and Life Safety are now standalone standards�

EOC management plans provide guidance for taking action to minimize risk and hazards� The organization can decide the format of the plan� The plan could exist as a set of plans, one for each functional area� Organizations could also develop a single document that covers all functional areas� The use of annexes, attachments, and action plans can provide details for the six functional areas� Maintaining a systematic approach when developing plans permits organizational members to better use the document or documents� Management plans should contain content that addresses performance objectives, compliance requirements, and performance evaluation specifics� Create a cross-checking process to document compliance with stricter regulatory requirements, other accreditation standards, and rules mandated by any authority with jurisdiction� The organization should identify risks and implement processes to minimize adverse impacts on buildings, grounds, equipment, occupants, and internal physical safety systems� Accomplish the following actions:

• Develop a written plan to address the management of the care environment • Designate persons to coordinate safety functions • Designate persons to intervene in events threatening life, health, or property • Review general safety policies as often as necessary but at least every three years • Respond to product safety recalls by taking appropriate actions • Ensure proper maintenance of all facility grounds and equipment • Conduct periodic evaluations to assess safety effectiveness • Assess staff knowledge behaviors during period environmental tours • Identify new or altered tasks that could pose risks in construction areas • Evaluate areas with changes in services to identify improvement opportunities

• Conduct environmental tours at least every six months in all patient areas • Conduct environmental tours at least annually in nonpatient areas

The American Osteopathic Association (AOA) represents more than 47,000 osteopathic physicians, promotes public health, encourages scientific research, and serves as the primary certifying body for osteopath doctors� The association serves as the accrediting agency for all osteopathic medical schools and healthcare facilities, including acute care hospitals� The osteopathic accreditation was developed in 1945� This enabled the association to assure that osteopathic students received their training through rotating internships and residencies in facilities that provided a high quality of patient care� The association also has deeming authority to accredit laboratories within accredited hospitals under the Clinical Laboratory Improvement Amendments of 1988� The association developed accreditation requirements for ambulatory care, surgery, mental health, substance abuse, and physical rehabilitation medicine facilities� The Healthcare Facilities Accreditation Program (HFAP) meets or exceeds the standards required by CMS to provide accreditation to all hospitals, ambulatory care/surgical facilities, mental health facilities, physical rehabilitation facilities, clinical laboratories, critical access hospitals, and stroke centers� HFAP’s surveying process and standards benefit from oversight by a wide range of medical professionals, including both allopathic and osteopathic disciplines� HFAP accreditation requirements are clearly tied to the corresponding Medicare Conditions of Participation� Base successful accreditation on the facility’s ability to correct deficiencies� Surveyors should possess experience and understand the many aspects of a healthcare facility and help make the survey process more realistic and educational� If a deficiency is identified, surveyors are able to draw from their experience and offer feasible solutions, usually on the spot� HFAP accreditation also is recognized by the federal government, state departments of public health, insurance carriers, and managed care organizations� Healthcare facilities seeking accreditation must comply with all the requirements listed in the latest edition of Accreditation Requirements for Healthcare Facilities.