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Compliance w it h Codes, St andards, Regulation s, and G uidelines Dale W oodin 2/06, r evis ed 2/07 Overview Healthcare is the second most regulated industry in the United States, trailing only the Nuclear Power industry. Few would argue the need for stringent codes, standards, regulations, and guidelines or the need for rigorous inspection of compliance, when considering the sacred trust of the patient and the patient’s family in the healthcare community. Seldom is a person more vulnerable than when they are receiving healthcare. Advances in diagnostic imaging allow us to visualize the previously undetectable, advances in surgical techniques reduce days and weeks of recovery time, advances in medications free people from the constraints of chronic illness. But each of these ‘miracles’ begin with a basic assumption of a clean and safe healthcare environment, optimized for treatment and healing. This optimized healthcare environment is founded on codes, standards, regulations, and guidelines that establish minimum expectations for design, maintenance, and operation intended to balance the potential for miraculous outcomes in care with the management of a myriad of risks created in rendering that care. Codes, standards, regulations, and guidelines establish compliance expectations from the cleaning agents used to scrub the floor to the radio-frequency-neutral environment of an MRI. Healthcare codes, standards, regulations, and guidelines are intended to optimize an environment for healthcare while protecting the patients, families, and caregivers from the inherent risks associated with that delivery of care. But just as diagnosis and treatment of a mysterious illness can be complicated, contradictory, and often expensive, effective recognition and compliance with multiple requirements, overlapping agencies, and seemingly contradictory goals can be difficult to understand, and often expensive to achieve. This chapter will identify the ‘key players’ in the regulation of the healthcare industry. It will thumbnail the healthcare-specific standards and the authorities having jurisdiction that enforce these standards. It will highlight federal governmental compliance agencies that have a specific influence on healthcare environments. It will address state requirements and, finally, it will illustrate the overlapping nature of national, state, and local authorities who enforce these standards. Part I - Healthcare Specific Standards and Authorities Having Jurisdiction The Joint Commission (TJC) The organization most associated with being the “watchdog” of the healthcare industry is the Joint Commission (formerly referred to as the Joint Commission on Accreditation of Healthcare Organizations or JCAHO). The stated purpose of the Joint Commission is to standardize practices and improve the quality of care for patients in American health care facilities. To this end, the Joint Commission operates an accreditation process based on surveys and compliance with standards. These standards, along with general suggestions for rendering high-quality patient care, appear in the Joint Commissions Comprehensive Accreditation Manual for Hospitals 1, which is issued annually. As the name suggests, the JCAHO standards are designed for a comprehensive evaluation of hospital rang ing from leadership and governance to medical staff and clinical practice. The chapter most aligned with facility management is the Environment of Care (EC) chapter. The EC chapter contains the overarching standards and their specific elements of perfor mance that establishes the compliance expectations for the design, maintenance, and operation of the healthcare facility. In developing many of the EC standards and inspection criteria, the Joint Commission incorporates the regulations of agencies such as the FDA, EPA, and OSHA and codes and standards and/or guidelines from organizations such as NFPA and AIA. Compliance with these federal rules and national standards provides the foundation for Joint Commission accreditation. In This chapter will only focus on TJC’s accreditation process for hospitals. The Joint Commission evaluation and accreditation services are provided for the following types of organizations: hospitals.(general, psychiatric, children’s and rehabilitation), health care networks, home care organizations, nursing homes and other long term care facilities (including sub-acute care programs), assisted living residencies, behavioral health care organizations, ambulatory care providers (including outpatient surgery facilities, rehabilitation centers and others), and clinical laboratories. 1 addition, the EC standards are comprised of many original concepts and industry best practices in the identification, assessment, and management of risks inherent to the delivery of healthcare. These include risk/vulnerability assessments for general safety, utilities management, medical equipment management, emergency preparedness, and environmental infection control. Table 6-1 provides an overview of the EC standards and their scope. In addition to the standards, JCAHO annually sets National Patient Safety Goals (NPSG) to serve as focus areas for improved safety performance. The NSPG’s are established through the analysis of actual patient safety incidents self -reported by healthcare organizations to the JCAHO (termed ‘Sentinel Event reporting’) Joint Commission accreditation is subject to renewal every three years. Although organizations are expected to remain in compliance with all JCAHO standards throughout their accreditation cycle, JCAHO schedules and conducts triennial visits to all accredited organizations to survey for compliance with the standards. The survey process has evolved gradually over time but 2003 signaled a rapid rate of change in the entire accreditation process including complete revision of the hospital standards, a n overhaul of the standards compliance scoring system, new requirements for organization self assessment for compliance (termed “Periodic Performance Review’), addition of Life Safety Code Specialists to the survey team for hospitals of 200 beds or greater, and plans to implement unannounced surveys in 2006. Joint Commission accreditation is a voluntary process. It is worth noting that Joint Commission on Accreditation of Hospitals (since changed to the Joint Commission on Accreditation of Healthcare Organizations) was founded in 1951 by several groups including the American Hospital Association and the American Medical Association. Accreditation has historically been viewed as the ‘gold seal’ of healthcare quality although the entire accreditation process it is somewhat time consuming and relatively expensive. Although other quality assurance programs such as ISO 9000 and the Baldrige Award have also been utilized by healthcare organizations, the vast majority of hospitals continue to contract with JCAHO for accreditation. JCAHO’s ‘deemed’ status and its impact on Medicare reimbursements is a key factor in this relationship between hospitals and JCAHO. SIDEBAR – Who, What, When, Where, Why, and How Who is the Authority Having Jurisdiction (termed ‘AHJ’), what will they inspect for, when does it occur, where are their jurisdictional boundaries, why do they exist, and how does it effect my hospital? A lot of questions for what can be a very confusing subject. Lets start with why? The mere existence of codes and standards does not ensure their compliance. Patients and their families trust that hospitals are designed, maintained, and operated a minimum quality standard. It is the role of federal, state, and local governments to develop or adopt codes and standards and they in turn grant the authority to enforce these codes and standards. The AHJ is that person, department, or agency that is granted the authority to ensure that public trust is met. So the who is the department or person such as the JCAHO surveyor, the CMS inspector, the fire chief or fire marshal, the health department inspector, the building official, the electrical inspector, and so on. Because of the broad and often overlapping nature of federal, state, and local codes, there may be multiple authorities enforcing similar types of requirements. What do they inspect for? JCAHO surveys for compliance with the Life Safety Code, as does CMS. The state building department may also, or they may survey for compliance with the International Fire Code. The local building official may review plans for approval based on either of these codes, or a locally develop fire code. The where part of the question, where is their jurisdiction, rests with government that granted their authority. Often this is geographical based on local community, state, or national. But not always, CMS authority is based on program participation; they have authority over all hospitals participating in the Medicare program but no authority over hospitals that do not receive Medicare funds. The when question appears fairly simple based on the function of the AHJ. Building officials will inspect at specific points of construction and at the completion of construction to grant the right to occupy the newly constructed area or facility. Authorities focused on the ongoing health and patient safety will survey the ongoing operations, often at scheduled intervals. This becomes a little more complex as in some cases an agent may be granted authority from more then one source. CMS contracts state agencies for hospital surveys. That same inspector/surveyor is also granted authority from their state. It is not uncommon to have a state authority to perform an inspection to grant occupancy status at the completion of construction only to also inspect that same hospital as a CMS surveyor leading to the question of which ‘hat’ they are surveying under; CMS or state? The question of how this effects my hospital is really where the ‘rubber hits the road’. Certainly this means you need to develop a working relationship with each AHJ but the complicating factor is when AHJ’s reference different codes for the same areas of inspection. Where this had the greatest impact was in the enforcement of the Life Safety Code (LSC). For years CMS enforced the 1985 edition of the LSC while JCAHO enforced the 1997 edition. The difference between these editions of the same code was significant as the 1985 LCS was based on construction concepts of separation and compartmentalization as the primary defense from fire death and injury where the 1997 LSC had moved to a standard of quick response sprinklers as the primary defense. This meant JCAHO-accredited organizations who received Medicare funds were required to maintain construction concepts of separation and compartmentalization (CMS reference to 1985 LCS) while also meeting the standard of quick response sprinklers (JCAHO reference to 1997 LSC), so hospitals and nursing homes were forced to follow the more stringent requirements of both the 1985 and 1997 editions. This inconsistency between the two national AHJ’s created a ‘belts and suspenders’ situation of excessive cost of construction and compliance with no added benefit. Through the collaborative efforts of the healthcare community, both JCAHO and CMS adopted the 2000 edition of the LSC in 2003 (although CMS has additional requirements modifying the 2000 edition). Similar conditions occur when various AHJ’s utilize different codes; for instance JCAHO and CMS enforcing the Life Safety Code while the state or community enforcing the International Fire Code. Although many points of these codes are similar, there are distinct differences that must be accounted for. The rule of thumb for compliance with differing standards is: the hospital is required to meet the most stringent requirements of each standard. Therefore it is essential that the Facility Manager have a strong working knowledge of each of the codes enforced by the various AHJ’s for their facility. Centers For Medicare & Medicaid Services The Centers for Medicare & Medicaid Services (CMS) is the federal agency within the Department of Health and Human Services (HHS) that administers the Medicare & Medicaid healthcare service programs. Prior to 2001, CMS was titled HCFA (Health Care Financing Administration). Hospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (COP) in order to receive Medicare/Medicaid payment. The 23 COP are a comprehensive set of standards on patient care and health ranging from Anesthesia Services to Utilization Review. Physical Environment is the COP of most relevance to Facility Managers as it contains the requirement that hospitals comply with the Life Safety Code®2, provide emergency power and lighting as well as emergency gas and water supply. CMS is organized with its central office in Baltimore and 10 regional offices (http://www.cms.hhs.gov/RegionalOffices/). The regional offices contract with state agencies [e.g. Illinois Department of Public Health (IDPH) is the CMS contracted inspection agency in Illinois] which perform inspections of hospitals and healthcare facilities for compliance with the COP. Citations for noncompliance with the Life Safety Code®, or requirements for emergency power and lighting, etc. are often referred to as “K-tags” from the prefix of the inspection elements on the Medicare-Medicaid Fire Safety Survey Report issued following CMS inspections. CMS inspection tend to be very thorough, often involving a team of engineers for several days or weeks, and rigid in their demands for rapid correction of the “K-tag(s)”. When congress created the Medicare & Medicaid program in 1965, HCFA (later CMS) did not exist. So congress determined that hospitals may demonstrate compliance with the COPs through Joint Commission (JCAHO) accreditation. Today, CMS may grant an accrediting organization "deeming" authority” and "deem" each accredited health care organization as meeting the Medicare and Medicaid COPs. Essentially, JCAHO had the original “deeming” authority, i.e. JCAHO accreditation provided the 2 The Life Safety Code (LSC) is developed and published by the National Fire Protection Association (NFPA). The LSC requires all health care buildings to have a certain level of fire protection features in existence. NFPA revises the LSC every three years to keep it updated with the newest technological advances, philosophies in fire protection, and lessons learned from actual fire incidents in health care facilities. The current 2000 edition is considered the best of all the previous editions. accredited hospital "deemed status". “Deemed status” meant that the hospital would not be subject to the rigorous and often punitive Medicare survey and certification process. The ability to confer “deemed status” on a hospital is not exclusive to JCAHO. CMS has granted “deeming” authority to other groups including the American Osteopathic Association (AOA). But JCAHO claims the ‘lion’s share’ of deemed status accrediting 82% of all Medicare-participating hospitals. Hospitals accredited by JCAHO received payments for Medicare-covered inpatient services of approximately $98 billion, or 90% of the $109 billion that was spent on healthcare in 20023 Although JCAHO-accredited hospitals have “deemed status” for compliance with the COPs, they are not exempt from CMS inspection. Through agreement with state agencies, CMS conducts validation surveys of JCAHO’s survey process. To validate how well the JCAHO process is assuring that the COPs are being met, CMS performs hospital validation surveys. The ‘traditional’ validation survey is conducted within 60 days of a JCAHO triennial survey to detect deficiencies that may not have been identified by the JCAHO survey team. Validation surveys can include 18-month surveys which monitor how well the JCAHO-accredited hospitals are complying with Medicare COPs midway between their 3-year JCAHO surveys, and allegation surveys, which are triggered by complaints or other reports of situations that pose potential threats to patient health and safety in JCAHO-accredited hospitals. CMS has the authority to remove deemed status of a JCAHO-accredited hospital where a state agency’s validation survey results in a finding that the hospital is out of compliance with one or more Medicare COPs SIDEBAR – Connecting the Dot’s - CMS vs. JCAHO A contentious but symbiotic relationship exists between JCAHO and CMS. CMS is charged by Congress with oversight of patient health and safety (i.e. assuring hospitals meet the COPs) but JCAHO was granted authority by congress to deem hospitals as complying with the COPs. CMS cannot require JCAHO to submit to a direct review of its process nor place JCAHO on probation while monitoring its progress as it can other deeming authorities (e.g. AOA). CMS’s oversight of JCAHO is limited to removal of deemed status from hospitals as a result of a validation survey. This places hospitals at the ‘front-line’ of an ongoing struggle between JCAHO and CMS. CMS uses validation surveys to ‘check-up’ on JCAHO, but the hospital receiving the validation survey is subject to intense scrutiny as the CMS inspectors attempt to find examples of non-compliance with the COPs, and in doing so, deficiencies in the JCAHO survey process. Although each validation survey is one more piece of data in the ongoing monitoring of JCAHO performance, it is a source of major disruption and has potentially expensive ramifications in terms of labor, materials, and community trust to the hospital being inspected. All deficiencies identified during a CMS validation survey require correction, often under very tight time limits, with major deficiencies potentially jeopardizing Medicare payments and even licensure. This contentious relationship came to a head in the July 2004 US General Accountability Office (GAO) Report: Medicare – CMS Needs Additional Authority to Adequately Oversee Patient Safety in Hospitals. In this report, the GAO calls for an increase of validation surveys from 1% of all JCAHOaccredited hospitals to 5%, and for expanded authority to oversee JCAHO survey process. When reviewing this report one could draw the conclusion that CMS desires to drive JCAHO ‘out if business’. But the reality is CMS does not have the presence in the field, even with contracting state agencies for inspections, to replace JCAHO’s surveyors or accreditation process. JCAHO is a voluntary accreditation process. Hospitals pay JCAHO for access to performance based standards, information on best practices, and for the on-site survey to accredit the performance of the organization. And for deemed status (i.e. seeking JCAHO accreditation rather then undergoing the CMS survey and certification process). But CMS validation surveys place hospitals on the ‘front-line’ between CMS and JCAHO subjecting them to intense scrutiny and disruption of services, all in the name of quality monitoring (and control). There has got to be a better way. 3 In 2002, JCAHO accredited 4,211, or 82%, of the Medicare-participating hospitals with the remaining 18% accredited by AOA or certified by state survey and certification agencies – source: July 2004 US General Accountability Office (GAO) Report: Medicare – CMS Needs Additional Authority to Adequately Oversee Patient Safety in Hospitals American Osteopathic Association The American Osteopathic Association (AOA) is a member association representing more than 56,000 osteopathic physicians. AOA’s Healthcare Facilities Accreditation Program (HFAP) has been granted "Deeming Authority" by the Centers for Medicare & Medicaid Services (CMS) to conduct accreditation surveys of Acute care hospitals and Hospital laboratories. The HFAP hospital accreditation is a recognized alternative to accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the laboratory accreditation program is a recognized alternative to accreditation by the College of American Pathologists (CAP) or JCAHO. The AOA has also developed accreditation requirements for ambulatory care/surgery, mental health, substance abuse, and physical rehabilitation medicine facilities. College of American Pathologists The College of American Pathologists (CAP) is a medical society serving nearly 16,000 physician members and the laboratory community throughout the world. CAP’s Laboratory Accreditation Program (LAP) has been granted "Deeming Authority" by the Centers for Medicare & Medicaid Services (CMS) to conduct laboratory accreditation surveys. It is also recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). National Fire Protection Association Of all the codes and standards referenced by facility managers the most commonly recognized are those of the National Fire Protection Association (NFPA). NFPA is an independent, international nonprofit association. It’s mission to reduce the worldwide burden of fire and other hazards on the quality of life by providing and advocating consensus codes and standards, research, training, and education. NFPA publishes approximately 300 codes, standards, and guides that are widely adopted by federal, state, and local governments and enforced by AHJ’s throughout the country. NFPA is not an AHJ and its codes and standards have no legal status unless they are adopted into law, e.g. CMS and state agencies, or referenced as a standard for accreditation, e.g. JCAHO. Nearly every facility managers bookshelf has a worn copy of the Life Safety Code and National Electric Code as well as the Standard for Healthcare Facilities (commonly referred to by its code number: NFPA 99). NFPA 99 is the one NFPA standard written specifically for healthcare but Life Safety Code and National Electric Code each have chapters and extensive section that specifically address healthcare occupancies and environments. Although governments and accrediting bodies often adopt the entire code, in some cases only certain sections may be adopted. It is important to distinguish exactly what has been adopted (what sections and from what edition of that code or standard). Each NFPA code or standard contain appendixes or annexes as additional information to explain specific sections of the code, to highlight complex subjects, or to offer implementation examples. The main body of the document (the chapters) is the mandatory language that is enforced by the AHJ. The appendix or annex is not mandatory language and is not enforceable. Confusion is often created if an AHJ mistakenly attempts to require compliance with a testing and maintenance procedure that is provided in the annex as an example of ‘one way to do it’ but should not be considered mandatory or the only way of doing it. Confusion often is centered on the edition and the references. When adopting a standard into law or for accreditation purposes, the specific edition of the code or standard must be identified. NFPA codes and standards are revised every three years but most authorities do not have ‘evergreen’ provision, i.e. the ability to simply adopt and reference the most current edition of that code. A prime example was CMS (originally HCFA’s) continued enforcement of the 1985 Life Safety Code (LSC) through years of revisions and improvement to the LSC finally adopting the 2000 edition of the LSC in 2003. The edition date is critical for new construction and renovation. As a code and standard evolves through multiple revisions there are typically new requirements added. Unless the requirement is identified as a retroactive requirement (required for existing facilities) the new requirement is only enforced upon construction or significant renovation. So older facilities are only required to meet the newer elements of that code upon construction or renovation. In the case of CMS use of the 1985 LSC up to 2003, the new requirements introduced in the 1988, 1991, 1994, and 1997 editions of the LSC were not enforced by CMS. Often the concept of an older facility being in compliance with the newer requirements of a revised code is termed as that requirement being ‘grandfathered’. This concept is incompatible with the Life Safety Code as it has requirements for new and existing facilities regardless of the date of construction. The key to separating new verse existing requirements is the date of the adoption of that code or standard verse the date acceptance of construction or renovation plans. Each NFPA code or standard references other codes and standards. If this reference is contained in a chapter, verse contained in an annex or appendix, then compliance with that reference code or standard is required. Again the edition date of the reference codes and standards is critical to determine the compliance expectations. For an example of this see the side bar Connecting the Dot’s – medical gas tank storage. NFPA 101 – Life Safety Code (LSC) is the cornerstone of both the CMS and JCAHO programs to ensure patient safety. Dating back to early 1900’s with the appointment of the NFPA Committee on Safety to Life, it was rooted in the investigations of several notable fires of the period involving 100’s of deaths - to analyzing the causes of this loss of life. This work led to a document on exit drills in 1913 and then in 1927 the Building Exits Code standards for the construction of stairways, fire escapes, etc., for fire drills in various occupancies, and for the construction and arrangement of exit facilities for factories, schools, and other occupancies. In 1966 the document was renamed the Life Safety Code. Today its scope includes those construction, protection, and occupancy features necessary to minimize danger to life from fire, including smoke, fumes, or panic. The LSC also establishes minimum criteria for the design of egress facilities so as to permit prompt escape of occupants from buildings, or in the case of hospitals where egress is not possible, compartmentalize the building into safe areas to implement the defend-in-place concept. Other provisions included in the LSC address protective systems, building services, maintenance activities, and other safeguards for adequate egress time or protection of people exposed to fire. The LSC is organized into base chapters which address means of egress, features of fire protections, building service and fire protection equipment, and interior finish, contents, and furnishings; and occupancy chapters (healthcare, business, assembly, high-rise, etc) that each draw from the base chapters to set their own set of requirements specific to the challenges of the occupancy. Because hospitals often contain multiple occupancies within the same facilities it is important to have a clear understanding of the definition of each occupancy and where the building design and construction creates adequate protection features (e.g. 2 hour rated fire barrier) between occupancies and where mixed occupancies occur. In the early 1970’s, in response to a series of multiple-fatality fires in healthcare facilities, Congress made compliance with the LSC mandatory for organizations receiving Medicare reimbursements. Coupled with the requirements of the JCAHO Plant Technology and Safety Management (PTSM) program, compliance with the LSC was universal for healthcare facilities. In addition to these national requirements, 34 states require the use of the LSC, in one form or another. A thorough working knowledge of the Life Safety Code, and the ability to translate its concepts into daily operation, is a fundamental skill required by all facility mangers. Although the JCAHO Statement of Condition and CMS Fire Safety Survey Report are valuable tools to aid in identifying certain key features of LSC compliance with the 2000 LSC they are not substitutes for reading the LSC, and its handbook, from cover to cover. NFPA 99 – Standard for Health Care Facilities was first published in 1984 as a comprehensive document combining the 12 documents under the charge of the NFPA Committee on Hospitals. These documents covered health care emergency preparedness, inhalation anesthetics, respiratory therapy, laboratories in health-related institutions, hyperbaric facilities, hypobaric facilities, inhalation anesthetics in ambulatory care facilities, home use of respiratory therapy, medical–surgical vacuum systems in hospitals, essential electrical systems for health care facilities, safe use of electricity in patient care areas of health care facilities, and safe use of high-frequency electricity in health care facilities. NFPA 99 is the basis of JCAHO standards on emergency power and lighting systems, medical gas and vacuum systems, and inspection and testing of medical equipment. Specific sections of the 1999 edition of NFPA 99 are referenced in the 2000 edition of the Life Safety Code and are the basis of CMS requirements for emergency power and lighting systems, and medical gas and vacuum systems. Multiple states have adopted sections of NFPA 99 as part of their state licensure requirements. NFPA 70 – National Electric Code (NEC) has been sponsored by NFPA since 1911. The original Code document was developed in 1897 as a result of the united efforts of various insurance, electrical, architectural, and allied interests. The NEC details the requirements for the practical safeguarding of persons and property from hazards arising from the use of electricity. The NEC applies to all types of structures, although it includes specific requirements for electrical construction and installation in healthcare facilities. The NEC is nearly universally adopted by all governing legislatures in all jurisdictions. Additional NFPA codes and standards which referenced in JCAHO EC standards: NFPA 1 – Fire Protection Code – contains general fire safety regulations for code enforcement and administration. NFPA 10 – Standard for Portable Fire Extinguishers NFPA 13 – Standard for the Installation of Sprinkler Systems – addresses the design and installation of automatic fire sprinkler systems NFPA 25 – Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems – this includes sprinkler, standpipe and hose systems, and fire pumps NFPA 72 – National Fire Alarm Code – covers the application, installation, location, performance, and maintenance of fire alarm systems NFPA 90A – Standard for the Installation of Air-Conditioning and Ventilating Systems American Institute of Architects The Guidelines for Design and Construction of Hospital and Health Care Facilities, commonly referred to as the AIA Guidelines is published by the Academy of Architecture for Health of the American Institute of Architects (AIA/AAH) is a professional society . Conceived as minimum construction requirements for hospitals, the document has evolved to include engineering systems, infection control, and safety as well as architectural guidelines for design and construction. The document is updated every three to four years to keep pace with new concepts and capabilities in the delivery of healthcare. The AIA Guidelines are referenced by JCAHO and 42 states. The AIA Guidelines trace their roots to the General Standards for the 1946 Hill-Burton Act where Congress funded a program for construction and improvement of hospitals. Through numerous revisions the document was re-titled the Technical Manual on Facility Design and Construction published by the Department of Health, Education, and Welfare. In 1984 the Department of Health and Human Services (HHS) removed the regulatory requirements related to minimum standards of construction of hospitals. However, the document was still being used for hospital mortgage insurance, for Indian Health Service construction projects, and by many state authorities having jurisdiction for licensure and registration. At that point HHS asked AIA to publish the document since it had moved from federal regulation to voluntary guidelines. Today, the Facilities Guidelines Institute (FGI) ensures that the document is reviewed and revised on a regular cycle with a consensus process by a multidisciplinary group of experts from the federal, state, and private sectors. The AIA Guidelines is a construction document not an operational document. As such it scope is the planning, design and construction of healthcare environments, not the operation of these environments. Often AHJ’s will misapply specific requirements such as ventilation air changes per hour to existing installations. It is unrealistic to expect existing systems and environments to meet current design standards without substantial renovation and system upgrade. AAMI Dialysis USP Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the federal agency within the Department of Health and Human Services (HHS) that safeguards the health of the American people by controlling and preventing disease. It conducts research and publishes results, often in the Morbidity and Mortality Weekly Report. This periodical is an up-to-date and thorough reference for health care facilities that want to stay ahead of new guidelines and regulations on such topics as infection control, infectious waste, and worker protection from bloodborne infectious diseases such as AIDS and viruses such as hepatitis B. CDC does not set nor enforce regulations. Joint Commission, various federal agencies, such as OSHA, EPA, and FEMA, and state departments of public health rely on CDC research and guidelines on setting their own standards for enforcement. In 2003 the CDC released the Guidelines for Environmental Infection Control in Healthcare (referred to as the EIC Guidelines). Intended as a comprehensive, “one stop shopping” approach to environmental infection describes control measures for preventing infections associated with air, water, and other elements in the healthcare environment. The EIC Guidelines focus attention to engineering and infection control concerns during routine operation, during construction, demolition, renovation, and construction, and during catastrophic events (flooding, sewage spills, loss of ventilation). Specific sections of interest to facility managers include: Air-Handling Systems Construction, Renovation, Remediation, Repair, And Demolition Infection Control and Ventilation Requirements for AII rooms, PE areas, and Operating Rooms Water Systems Environmental Services The EIC Guidelines also addressed facility issues formerly addressed in previous CDC documents including the Guideline for Prevention of Nosocomial Pneumonia and the Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis. In addition to the EIC Guidelines, CDC has issued Guidelines through the Health Care Infection Control Practices Committee (HICPAC) which are relevant to the planning, design, construction and operation of healthcare facilities including: Guideline for Hand Hygiene in Health-Care Settings Guideline for infection control in health care personnel, Guideline for Prevention of Surgical Site Infection, One of the operational units within CDC is the National Institute for Occupational Safety and Health (NIOSH) which recommends occupational safety and health standards and provides research, training, and technical assistance to promote healthful working conditions. The Occupational Safety and Health Administration (OSHA) relies heavily on NIOSH research in writing new regulations. Several NIOSH guidance documents are relevant to the planning, design, construction and operation of healthcare facilities including: Guidance for Protecting Building Environments from Airborne Chemical, Biologic al, or Radiological Attacks Glutaraldehyde – Occupational Hazards in Hospitals Violence – Occupational Hazards in Hospitals Best Practices – Surveillance of Blood and Body Fluid Exposure Administrator’s Guide to TB Respiratory Protection Program in Health Care Facilities PART II - Governmental Compliance Agencies that have a Specific Influence on Healthcare Environments Governmental compliance agencies are those organizations that the government-federal, state, or localhas endowed with the authority to establish regulations and enforce them. Many times, the rules these agencies promulgate have the force of law, and violators may be subject to civil and even criminal penalties. Other times, they may publish only guidelines, but still base their ins pections and citations on these recommendations. Often government entities separate their compliance responsibilities from their public outreach or information/education programs in different divisions or sections so it is possible to obtain guidance without triggering an inspection. Occupational Safety and Health Administration The Occupational Safety and Health Administration (OSHA) is a federal agency within the Department of Labor, created by the 1970 Occupational Safety and Health Act. This act requires employers to ensure safe and healthful working conditions for employees in the workplace. The act gave every employee the right to a reasonably secure, risk-free environment that the employer must maintain. Unlike the previous agencies and code formation and enforcement groups identified, patient health and safety is not a stated goal of OSHA. Rather, its focus is on employee safety. But given the complexity of services provided, and the inherent risks of many of these services, compliance with OSHA is a key concern for facility managers. Moreover, the Joint Commission requires compliance with basic OSHA safety regulations. OSHA has issued regulations and guidance for health care facilities including the control of waste anesthetic gas, the handling of cytotoxic (antineoplastic) drugs, the use of X-ray equipment, and the protection of workers from occupational exposure to bloodborne pathogens and hazardous chemicals. In addition, OSHA has numerous general industry regulations that affect health care facilities, especially on general safety. For example, there are OSHA rules covering Asbestos, the use of ladders and scaffolds, the condition of exits, electrical safety, entry into confined spaces, lifting techniques, safety guards on shop equipment, and the use of personal protective equipment. OSHA’s authority is not limited to enforcement of its specific regulations. A key concept of OSHA is its ‘General Duty Clause’, namely that the employer must provide "employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm" to employees. For a listing of OSHA standards that apply to healthcare go to: Table X-X OSHA Standards & Intent of the Standard OSHA enforces its requirements through workplace inspections. These can occur for five reasons: Imminent danger Catastrophes or fatal accidents Employee complaints Programmed inspections for high-hazard industries Follow-up inspections Inspections are conducted to determine whether any safety and health hazards have been overlooked by the employer and, when necessary, citations are issued and fines levied. If the potential harm represents an immediate threat to the health or life of employees, OSHA will take immediate steps to remove the hazard. Otherwise, OSHA may issue a citation that may still result in penalties or civil or criminal fines. However, OSHA assures employers that consideration is given to the appropriateness of the penalty, the severity of the violation, the size of the facility, the good faith of the employer, and the record of previous violations. OSHA is organized with its central office in Washington, DC and 10 regional offices (go to www.osha.gov/html/RAmap.html for location and contact information on regional and area offices). For many years, healthcare ‘flew below the radar screen’ with OSHA inspections typically only occurring as a result of accidents or employee complaints. But beginning in 20 00, hospitals have reported OSHA inspections in increasing numbers resulting in some significant fines. 2004 JCAHO and OSHA announced an educational partnership to raise awareness of worker safety issues that are unique to the healthcare environment. OSHA has developed many resources to help staff and supervisors understand what is expects from them. In This awareness is intrinsic to an effective safety program, because OSHA was established to ensure workplace safety. In many ways, OSHA standards and guidelines relate directly to the health care facility. Understanding them can greatly enhance safety and the smooth operation of the facility. OSHA is organized US. Environmental Protection Agency The Environmental Protection Agency (EPA) is the federal agency which exercises control over the release of harmful materials into the environment. As with OSHA, the EPA has written both regula tions and general guidelines. These rules and recommendations define which substances can be hazardous to human health and the environment, outline formal procedures for handling these materials, govern the operation of waste disposal sites, and establish a system for dealing with environmental accidents such as leaks or spills. As patient care becomes more and more complex, health care facilities increasingly rely on hazardous chemicals during routine operation. Whereas OSHAs Hazard Com munication Standard covers the use of these substances by employees in the performance of their jobs, EPA rules apply primarily to the effects of the materials on the environment. The EPA's purview also extends to infectious wastes because they, too, possess a potential to endanger humans and the environment, although the degree of possible harm remains a matter of debate. In order to effect a comprehensive system of control for dangerous wastes, the EPA has published numerous rules and guidelines. The following have the greatest effect on health care: Clean Air Act: In 1970, Congress passed this act to empower the EPA to set permissible levels for the emission of hazardous substances into the air. Congress strengthened this act by passing revisions in 1990. Clean Water Act: In an effort to buttress the 1972 Federal Water Pollution Control Act, the Clean Water Act was passed in 1977. This act limits the discharge of hazardous substances into our waterways. The act established the National Pollutant Discharge Elimination System (NPDES), which requires permits for the discharge of harmful materials into water. In 1987, this act was bolstered by a congressional reauthorization. Toxic Substances Control Act (TSCA) of 1976: This legislation regulates the manufacture, distribution, and use of toxic chemicals. It requires manufacturers to notify the EPA when proposing new chemicals and regularly assesses existing hazardous chemicals. The TSCA may limit or prohibit the use of some chemicals, and this may have an impact on health care. For example, the use of polychlorinated biphenyls (PCBs), except in a totally enclosed system, has been disallowed. The transformers and capacitors in some older facilities may contain PCBs and may not always be regarded as being in a totally enclosed system. Resource Conservation and Recovery Act (RCRA) of 1976: This is the act that has the greatest impact on health care facilities and other waste generators. It establishes a system for the control of hazardous wastes from the time they are generated until their final disposal, from "cradle to grave: "The RCRA divides waste generators into categories based on the amount of waste generated; requires permits for generators, transporters, and disposal facilities; and sets up a manifesting -system whereby wastes are tracked from generation to disposal. o Comprehensive Environmental Response, Compensation, and Liabilit y Act (CERCLA) of 1980: Called Superfund, this act allocates funding and direction for the cleanup of contaminated waste sites. It also confers liability on all involved with the waste site, even if they did not directly cause the contamination. Under CERC LA, hospitals have had to help pay for the cleanup of waste sites to which they have sent their wastes. o The Superfund Amendments and Reauthorization Act (SARA) of 1986: This act reauthorizes and strengthens CERCLA. In addition, Title III of SARA establish es a system of response in the event of an environmental disaster. Title III gives some hospitals additional environmental responsibilities. It requires hospitals to coordinate environmental safety plans with community agencies. Infectious Waste Guidelines: In 1986, the EPA published guidelines for the handling, treatment, and disposal of infectious waste. These are guidelines and do not pos sess the force of law. However, because of well-publicized medical waste dumpings and societal concerns, the EPA has announced it will reconsider its policy of just publishing guidelines on this subject. Taken together, these EPA rules and guidelines represent a broad base of responsibility for health care facilities. The laws empowering the EPA are summarized in figure 61. In addition, regulations are expanding and changing almost daily, as is evident from the rules that have been strengthened, reauthorized, or reconsidered. Compounding the problem, individual citizens may sue for damage that results from the release of a hazardous substance. Thus administrators and personnel should be aware that the EPA is a major source of regulatory control for them. However, the EPA can also act as an excellent source of guidance and information. It publishes informative guides to h elp facilities understand and comply with regulations, such as its 1986 Understanding the Small Quantity Generator Hazardous Waste Rules: A Handbook for Small Businesses and EPA Guide for Infectious Waste Management. Table 6-2 lists the EPA regional offices Figure 6-1 Laws Empowering the EPA Table 6-2 EPA Regional Offices U.S. Food and Drug Administration The Food and Drug Administration (FDA) is charged with supervising the development, testing, and monitoring of food and drug products and medical equipm ent. The FDA requires the health care facility to take corrective action to protect the safety and wellbeing of patients, staff, and visitors whenever information on a hazardous product is brought to the facility's attention. It is the responsibility of t he facility to obtain, evaluate, and act upon all information concerning hazards of the equipment, food, and medication it uses. Until the mid-1970s, the FDA had no well-defined control over medical devices. However, in 1976, the Medical Device Amendments to the Federal Food, Drug, and Cosmetics Act (which established the FDA) set up an FDA Bureau of Medical Devices (BMD). The BMD is now called the Center for Devices and Radiological Health, and it possesses the authority to ban or recall products that pr esent a substantial and unreasonable risk for harm. The severity of the hazard determines whether the product is removed from the marketplace. Even the risk is not severe enough to recall the product, the manufacturer still must notify users of the hazard(s). Depending on the situation, products are recalled through letters, postcards, and telegrams. The FDA may require the manufacturer to send a return-receipt letter to the facility. This document, when signed by an authorized employee of the facility, officially acknowledges that the facility has received the recall notice. It then becomes the facility's responsibility to initiate an organized procedure to communicate the necessary information to all appropriate staff and make arrangements to replace the product, if necessary. If the facility does not take some measures and the recalled product causes a serious accident, much of the liability may be transferred to the facility. The FDA has also established the Medical Device and Laboratory Product Problem Reporting Program, whereby health care workers can report problems in products they use. This program is geared toward improving communication of hazards resulting from medical products. For further information, contact the Practicioner Reporting System. Other sources of information on food, drug, or medical device hazards include the FDA Enforcement Report, available from the Press Office, Food and Drug Administration, and the Health Device Alerts, available from the Emergency Care Research Institute. ADA FCC FEMA OHS OEP U.S. Nuclear Regulatory Commission The Nuclear Regulatory Commission (NRC) oversees the operation of nuclear power facil ities and regulates the handling, use, and disposal of radiological materials. Hospitals may use radiological substances in several areas of operation including nuclear medicine, radiology, clinical laboratories, and research laboratories. The types of materials used in hospitals usually result in low -level radioactive waste. Radioactive waste is unlike infectious and hazardous waste in that the hazardousness of this waste can only be completely removed by time. That is, over time, radioactive materials decay and become less dangerous. Some hospital radiologicals decay within days. However, for others, the rate of radioactive decay, called the half-life, can be very slow; some require thousands of years to become thoroughly harmless. Meanwhile, these substances emit dangerous radiation, which has been associated with cancers, birth defects, and other health problem s. As a result, these materials must be carefully handled during use and adequately contained for disposal. Hazardousness and half-lives vary widely among radiological materials, as do disposal techniques. Contaminated materials may be incinerated, put in landfills, allowed to decay in storage, or disposed of through the sanitary sewer, depending on their type and the applicable regulations. The NRC has published regulations governing these practices in its Standards for Protection Against Radiation. State Requirements Individual states have requirements for health care facilities on many of the same topics as federal agency regulations. However, the state requirements may be more rigorous or extensive than federal standards. These state rules are usually enforced through licensure or the periodic inspection and relicensure process. States may legislate practices in many areas, including: Occupational safety and health: Federal OSHA gives states the option of implementing their own workplace safety and health programs rather than adopting the federal program. These state OSHA programs must be at least as stringent as the federal program. Hazardous waste: States may establish their own EPA hazardous waste management agencies to assist in compliance with EPA rules and possibly expand on them. Infectious waste: Although this is rapidly changing, the greatest source of rule making for infectious waste is state agencies. Regulations are usually issued by the board of health or state EPA, if there is one. In addition, local sewer districts may have rules for the disposal of hazardous or infectious materials through the sewer. Worker's compensation: A common denominator for all states is the existence of workers compensation laws, which are generally enforced by the state's attorney general or similar agent. The penalties for failure to comply with these laws, as well as the actual compensation to injured employees, are cumulative and can cause financial hardship for any size facility. Effective accident prevention and comprehensive safety programs can minimize unreasonable worker's compensation costs. Fire and health codes: The state or local fire authority, normally the fire marshal's office, verifies that fire safety requirements are met by using its own state codes and National Fire Protection Association (NFPA) codes (which are voluntary codes). In addition, health or fire department officials, or the authority having jurisdiction, will verify compliance with required infection control techniques, sanitation practices, proper storage and disposal of hazardous materials, and training of staff in the proper identification and control of hazardous substances. Because state and local requirements on these and other subjects may differ from or expand upon national standards, it is crucial that health care facilities gain an aware ness of the regulations in their area that affect them. As with federal mandates, facilities should be aware that regional requirements may change as new information becomes available. Abiding by state and local rules can provide a strong foundation for compliance with federal and voluntary standards. Thumbnail ISPH and OSPA Building Codes To ensure that safety standards are followed when new buildings are constructed or existing ones are repaired, building codes have been established. The codes may be adapted either at the local or state level and are enforced by a building official. The typical building code applies to the construction, alteration, addition, repair, removal, demolition, use, location, occupancy, and maintenance of all buildings and structures. Three model building codes have been developed and are used within the United States. These codes and the organizations that publish them are as follows: • BOCA National Building Code: Building Officials and Code Administrators International, Inc. • Standard Building Code: Southern Building Code Congress International, Inc. • Uniform Building Code: The International Conference of Building Officials Each of these groups also publishes companion codes, such as mechanical, plumbing, and gas codes, which may apply to construction projects. The staff of each organization is available to provide interpretations of the various codes for members. Educational programs, monthly publications, technical documents, and annual conferences that include continuing education opportunities related to code issues are also provided by these organizations. Some jurisdictions may choose to write their own codes in lieu of adopting one of the model codes. It is not mandatory for the codes to follow established building codes. In addition to these codes and standards, many health departments have promulgated regulations on constructing and equipping medical facilities. These standards typically address functional program requirements and may also include references to building codes or NFPA 101. Many states reference a Public Health Service document entitled Guidelines for Construction and Equipment of Hospital and Medical Facilities. Voluntary Compliance Organizations just as not-for-profit health care facilities have always, in a way, "volunteered" medical services to the community, so have voluntary organizations set standards for the health care industry. These organizations and their standards are highly regarded, and their accreditation of a facility is often evidence that the facility places high priority on safety and health. Voluntary organizations act out of a sincere desire to enhance patient care and ensure that the facility is a safe environment for its inhabitants. Moreover, many governmental agencies look to these voluntary groups for technical assistance in developing regulations for the health care industry. When incorporated into federal, state, or local regulations, voluntary standards become compulsory. The NFPA, the Joint Commission, the American National Standards Institute, and the Compressed Gas Association represent just a few of the myriad helpful voluntary organizations that are too numerous to mention. Trade groups exist for practically every health care facility safety topic imaginable. In addition, many states or regions have their own health care associations. Health care facilities are urged to make use of the many professional resources available to them through these organizations. National Fire Protection Association The National Fire Protection Association (NFPA) is an independent, not-for-profit organization that develops consensus standards for essential fire safety in all building types in the country, including health care facilities. The NFPA draws on expert advice from various fields in developing its codes; it is widely recognized as a reliable source of fire protection guidance. Consequently, NFPA codes have been accepted by the federal and most state and local governments as the basis for their fire prevention codes. The Joint Commission also exchanges information with the NFPA through active participation on NFPA committees. The two most important standards for health care facilities are NFPA 99, Standard fo r Health Care Facilities, and NFPA 101, Life Safety Code. NFPA 99 establish criteria for safeguarding patients and health care personnel from fire, explosion, electrical hazards, and related hazards associated with locations where anesthesia is administered. (NFPA 99 is part of over 50 publications that apply to health care facilities.) The sections of NFPA 99 that more specifically apply to health care facilities are Respiratory Therapy, Essential Electrical Systems for Health Care Facilities, Safe Use of Electricity in Patient Areas of Hospitals, Health Care Emergency Preparedness, Laboratories in Health Related Institutions, Medical Surgical Vacuum Systems in Hospitals, and Use of Inhalation Anesthetics (Flammable & Nonflammable). The codes for life safety are established in NFT'A 101, which considers a number of elements such as early warning detection and alarm systems, fire partitions, exit identifi cation and lighting, sprinkler systems, building care maintenance, and storage for all occupied building s. Included in the code are requirements for emergency preparedness plans and drills, exit arrangements, portable fire extinguishers, and waste-handling systems. The disaster preparedness section provides information necessary for the preparation and implementation of a facility's individual plan. [Note: In some areas of the South and Midwest, the Uniform Fire Code (UFC) sometimes supersedes NFPA codes. Those not sure of the status of codes in their region should check with their local and state regulatory agencies.] A source of overall information on the latest developments in fire protection systems, equipment, and techniques is the latest edition of the NFPA Fire Protection Handbook. An NFPA training film entitled Fire Safety in Health Care Facilities also provides an overview of fire protection methods for health care. Another NFPA film, Evacuation of Medical Facilities, focuses on successful evacuations from a health care facility. The NFPA is also a source of training materials of all sorts, including books, pamphlets, posters, slide programs, films, and training manuals for both in-house and home fire protection training. A number of seminars are offered each year, and technical advice is available. An individual membership is beneficial for the person most responsible for the fire safety function in each facility. American National Standards Institute In 1918, several professional organizations and government agencies formed the Ameri can National Standards Institute (ANSI) to coordinate the issuance of standards by organizations with similar responsibilities. The ANSI's goal is to minimize duplication and conflict among the numerous regulations affecting business and industry. The organization works to assist voluntary organizations and governmental agencies in developing regulations, while also seeking a consensus on the need for standards. The ANSI conducts a review process by which a regulation or requirement is approved as an American National Standard. In order to achieve this approval, the agency issuing the standard must be able to provide evidence that all those affected by the standard were allowed either to participate in or comment on the development of the regulation. With this approval, the standard is then generally recognized and accepted for use. Approval from the American National Standards Institute extends to regulations affecting health care as well. In addition, through its approval process ANSI ensures that when the health care industry is affected by a regulation, it has a say in the standard's development. Health care managers and administrators should make use of this opportunity to contribute to the process by which standards that directly affect them are developed. Compressed Gas Association Health care facilities routinely use a number of compressed gases throughout the facility, including ethylene oxide, anesthetic gases, and oxygen. Because these gases are stored under tremendous pressure, even minimal disturbance can cause this pressure to be released in a destruct ive manner. If not handled and stored with great caution, compressed gases pose a very serious danger of explosion, injury, and property damage. The Compressed Gas Association (CGA) was founded in 1913 as a not-for-profit trade association representing the compressed gas industries. It provides technical advice and safety coordination for businesses in these industries. However, the CGA is also concerned with the handling of compressed gases wherever they are used, including in health J' care facilities. It provides a variety of services to users of compressed gases, including technical publications and audiovisual materials. The CGA also advises the NFPA in developing compressed gas standards. The CGA is an excellent source of information on the safe use of compressed gases. Comparing Applicable Regulations As this chapter has shown, the voluntary standards and governmental regulations affect ing health care are many and various. Table 6-3 summarizes the agencies and voluntary organizations discussed herein and their scope. Moreover, requirements are often duplicated by several agencies. Even worse, different agencies may publish rules or guidelines that actually conflict. Compounding the problem is the rapid pace at which some requirements grow and change, particularly those on hazardous/infectious wastes. The sheer number and complexity of requirements, however, become less threaten ing if viewed in the right light. Many of the regulations overlap because the responsibili ties of the various agencies overlap. For example, both the CDC and the EPA publish guidelines on infectious waste management, and NFPA codes are integrated into joint Commission accreditation criteria. Understanding these examples will help in learning to view the legislation and guidelines as a manageable body of requirements. In addition, part of the reason for any discrepancies that exist among the rules is the relative newness of the problems, especially in hazardous and infectious materials regulations. Governmental agencies are learning to work in concert on these concerns as they gain greater experience in dealing with conflicting standards. Summary Most compliance organizations work to make information and assistance available to those who need it. Many regulatory officials realize that their standards may seem confusing and try to enhance understanding through publications, training, and direct mailings. These agencies can also be contacted by mail or telephone with questions or concerns, and many agencies operate hotlines on specific topics. Concerned personnel who are willing to take the time will find that using the many resources at their disposal will make regulations less daunting and compliance an achievable goal. Table 6-1 (New) Summary of the JC Environment of Care Standards EC Standard 1.10 Manage safety risks. 1.20 Maintain a safe environment. 1.30 Prohibit smoking 2.10 Identify and manage security risks. 3.10 Manage hazardous materials and waste risks. 4.10 Address emergency management. 4.20 Conduct emergency management drills regularly. 5.10 Manage fire safety risks. 5.20 Designed and maintain environments to comply with the Life Safety Code®. 5.30 Conducts fire drills regularly. 5.40 Maintain fire-safety equipment and building features. 5.50 Implement Interim Life Safety Measures when a EC.5.20 is not met 6.10 Manage medical equipment risks. 6.20 Inspect, test, and maintain medical equipment 7.10 Manage utility risks. 7.20 Provide a reliable emergency electrical power source. 7.30 Inspect, test, and maintain utility systems. 7.40 Inspect, test, and maintain emergency power systems. 7.50 Inspect, test, and maintain medical gas and vacuum systems. 8.10 Establish and maintain an appropriate environment. 8.30 Manage the design and building of the environment (construction, renovation, and alteration) 9.10 Monitor conditions in the environment. 9.20 Analyze identified environment issues and develops recommendations for resolving them. 9.30 Improves the environment. Scope Empower a safety officer, perform proactive risk assessments to establish a management plan & policies Conduct environmental tours Develop and implement a policy and compliance monitoring Perform proactive risk assessments to establish a management plan & policies Perform proactive risk assessments to establish a management plan & policies. Include hazardous gases, vapors, solids, liquids, drugs, and radiological material Perform hazard vulnerability assessment to guide preparedness and contingency planning Conduct drills semi-annually, coordinate with community services, critique and improve performance Perform proactive risk assessments to establish a management plan & policies Assess compliance with Life Safety Code®, prepare a Statement of Conditions Conduct quarterly drills of equipment operation and human response, critique and improve performance Inspect, test, and maintain fire safety equipment and building features Develop assessment criteria of fire deficiencies caused by construction/remodeling, implement measures to compensate Inspect incoming equipment, risk assess for PM strategies Life Support equipment, non-life support, sterilizers, and dialysis water testing Perform proactive risk assessments to determine critical utility systems, set testing and contingency plans. Requirements for locations and services supplied by emergency electrical power per NFPA 99 Inspection and testing critical (including life support and infection control) utility systems Monthly testing of emergency generators and transfer switches Testing when system is breached, control and shutoff labeling, routine inspection, testing, and maintenance Lighting, ventilation, and furnishings of patient care environments Reference AIA Guidelines on Healthcare Facility Design and Construction, perform a construction risk assessment and implement measures to eliminate/reduce risks Annually evaluate safety performance Safety committee organization, monitoring activities and recommendations to organizational leadership Monitor and report results of safety improvements Internet Links to Agencies, Associations, and various Groups AIA AOA JCAHO CMS NFPA CDC OSHA NFP www.aia.org/aah_gd_hospcons www.osteopathic.org www.cms.hhs.gov www.nfpa.org www.nfpa.org/aboutthecodes/list_of_codes_and_standards.asp Table X-X OSHA Standards & Intent of the Standard Note: Guidelines that have been enforced under the General Duty Clause are included Asbestos - 29 CFR 1926.1101 To protect workers from exposure to asbestos fibers during construction, alteration, renovation, repair, or maintenance of structures. Benzene - 29 CFR 1910.1028 To protect workers from exposure to benzene which is most typically found as a product component in medical laboratories and maintenance departments where petroleum and similar chemicals are found. Bloodborne Pathogens - 29 CFR 1910.1030 To protect employees from occupational exposure to blood, blood products, human body fluids and human tissue that may be potentially infectious. Compressed gases – 29 CFR 1910.101 Reference Compressed Gas Association Pamphlets for the visual inspection, in-plant handling, storage, and utilization of all compressed gases in cylinders or portable tanks. Confined Space - 29 CFR 1910.146 To ensure that employees are protected from confined space entry hazards which can result in serious and even fatal injuries. Examples of confined spaces are boilers, pits, man holes, tanks, building crawl spaces and other areas that meet the following criteria. Construction - 29 CFR 1926 To protect employees from injuries on construction sites. Construction on healthcare facilities, where the facility acts as a general contractor or in-house projects utilizing employees, are covered under this standard. Corrosives – NIOSH guidelines To protect workers from eye, skin and other injuries where healthcare organizations use products with corrosive properties. Corrosives are typically found in labs, pharmacies, and clinical areas where acids, bases, hazardous drugs, and high level quaternary disinfectants are present. In addition, exposure to corrosives may occur in engineering areas, in central sterile areas with EtO, in print shops, near battery charging areas, in some compressed gases (chlorine, fluorine) and in various support areas. Also, vendors and contractors may bring corrosives into the organization’s environment. Electrical Safety Work Practices - 29 CFR 1910.333 To protect employees from electrical shock or other injuries resulting from direct or indirect contact with electricity. Emergency Plans - 29 CFR 1910.38 To protect employees from fires and other emergencies. Emergency Response - 29 CFR 1910.120 (q) To protect employees from exposure resulting from uncontrolled release of chemicals in the workplace. This includes exposures resulting from chemical spills or releases as well as treatment of contaminated patients. Ergonomics – OSHA proposed standard To alert healthcare organizations to the concept of ergonomics in the work environment. Violations for ergonomic injuries are cited under the General Duty Clause. Ethylene oxide - 29 CFR 1910.1047 to protect employees from exposure to ethylene oxide (EtO) in the workplace. Eyewash/Emergency Shower - 29 CFR 1910.151(c) To offer protection for employees from contact exposure to injurious materials and chemicals in the work place. Emergency eyewash equipment and drench showers are provided for the emergency treatment of the eyes and body of individuals who have been exposed to injurious materials and chemicals. Fire Prevention Plans - 29 CFR 1910.38(B) To protect the employees from fire hazards in the workplace by ensuring that the staff are aware of and familiar with all materials that might ignite or accelerate a fire and the proper storage of those items. Forklift - 29 CFR 1910.178 This section of the Code contains safety requirements for forklifts, lift trucks, and hand trucks, all referred to as “trucks” in this guideline. The actual title of the Code is “Power Industrial Trucks.” Forklifts are found in warehouses and other material storage areas. Formaldehyde - 29 CFR 1910.1048 to protect workers from exposure to formaldehyde by identifying employees at risk to exposure, monitoring the workplace for exposure levels, and applying work practice and engineering controls to ensure that employee exposure to formaldehyde does not exceed the PEL. General Duty Clause - OSH Act, Section 5(a)(1) To inform employers that they must provide a safe workplace for employees so they will not be injured or become ill. Glutaraldehyde - guideline To protect employees from exposure to glutaraldehyde in the workplace. Although there is no specific section of the Code that addresses a permissible exposure limit, OSHA may enforce exposure concerns citing the General Duty Clause based on NIOSH and ACGIH recommended ceiling limits. Hazard Communications - 29 CFR 1910.1200 Requires healthcare, like other employers, to inform employees about potential health hazards resulting from exposure to chemicals used or stored throughout the workplace. Hazardous Drugs - guideline to protect employees from exposure to a variety of hazardous drugs that may be found in the workplace. Occupational exposure settings may include hospitals, physician’s offices, and home health care environments. Hazardous drugs include cytotoxic, investigational, and aerosolized drugs, such as pentamidine or ribavirin. Individuals at risk for exposure include pharmacists, nurses, physicians, and other healthcare workers who mix, administer, transport or dispose of hazardous drugs. Indoor Air Quality – guideline To assist healthcare organizations in improving indoor air quality (IAQ) Ladder Safety - 29 CFR 1910.25, 1910.26, & 1910.27 To provide guidance for the safe use of ladders in the workplace. Laser Safety – guidelines To provide a general overview to lasers, laser uses, laser hazards and hazards analysis that are required to provide appropriate background for understanding the applicable industry standards and regulatory requirements. Latex – guideline To assist healthcare organizations in preventing allergic reactions to natural rubber latex among workers who use gloves and other products that include latex. Products containing latex include: medical supplies, personal protective equipment, and numerous household objects. Exposures to latex may result in skin rashes; hives; flushing; itching; nasal, eye, or sinus symptoms; asthma; and shock. Laundry Operations - 29 CFR 1910.264 To provide those health care facilities who conduct laundry operations with guidelines to protect their employees from the dangers they are exposed to in the workplace. Lead - General Industry, 29 CFR 1910.1025, Construction Industry, 29 CFR 1926.62 To protect employees from exposure to lead in the workplace. Although the preferred method is to have no lead in the workplace, it is recognized that this is not possible in certain situations. Lead can be found in old piping and in paint. In those situations, management of or preferable engineering methods must be used to limit exposure to that prescribed in the Code. Lockout/Tagout - 29 CFR 1910.147 To protect employees from being injured by exposure to hazardous energy: hydraulic, steam, pneumatic, electrical, etc. Machine Guarding - 29 CFR 1910.212-215 To protect machine operators and other employees from injury caused by unguarded machinery in the machine area from hazards such as those created by point of operation, ingoing nip points, rotating parts, flying chips, and sparks. Means of Egress - 29 CFR 1910.37 To allow employees to exit from fire hazards in the workplace by ensuring that the building is protected, illuminated and maintained. This section is intended to also address nonclinical areas (e.g., administrative areas, maintenance, dietary, etc.). Mercury - 29 CFR 1910.1000 To protect employees from exposure to acute and long-term health effects of mercury. OSHA regulates exposure to mercury through the Air Contaminant Standard, 29 CFR 1910.1000, including a PEL of 0.1 mg/m3 or 0.05 mg/m3 as an 8-hour TWA for mercury vapor. Methyl Methacrylate - 29 CFR 1910.1000 To protect employees from exposure to methyl methacrylate in the workplace, often used as a bone glue and in other adhesives. Although there is no specific section of the Code describing how OSHA wants you to deal with methyl methacrylate, the chemical is listed in 29 CFR 1910.1000 having permissible exposure limits (PEL), which employees are allowed to receive. Methylene chloride - 29 CFR 1910.1052 To protect employees from exposure to methylene chloride (MeCl) in the workplace. Methylene chloride is often found in maintenance departments, housekeeping, dietary and grounds areas of hospitals. MeCl acts as an anesthetic in short-term exposures and is also a suspect carcinogen. It may cause irritation and burns to skin and eyes. Mycobacterium tuberculosis (TB) - guideline For the prevention of spreading Mycobacterium tuberculosis (TB) among healthcare workers and others within the healthcare facility. There is no specific standard governing TB, but OSHA recognizes the CDC Draft Guidelines for Preventing the Transmission of Tuberculosis in Healthcare Facilities, 2nd edition, which was published in the October 28, 1994 Federal Register. OSHA also applies the “General Duty Clause” to the prevention of the spread of TB. Noise Exposure - 29 CFR 1910.95 To assist healthcare organizations in protecting their employees from high levels of occupational noise exposure. Noise concerns can be in the engineering and maintenance areas, laundry, and food service. Oxygen - 29 CFR 1910.104 This section of the Code applies to the installation of bulk oxygen systems (more than 13,000 cubic feet) at hospitals and the use of oxygen in health care facilities. These systems and cylinder storage containers pose potential dangers to anyone who works with or around them. Personal Protective Equipment (PPE) - 29 CFR 1910.132 To ensure that employers provide protection of eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers. Personal protective equipment (PPE) shall protect employees from injury or impairment to any part of the body caused through absorption, inhalation or physical contact. Power Tool Guarding - 29 CFR 1910.243 To protect power tool operators and other employees from injury caused by unguarded tools. Radiation Exposure - 29 CFR 1910.97 To protect healthcare workers from exposure to radiation. Nonionizing radiation can be infrared radiation (IR), ultrasound, microwave, lasers, ultraviolet radiation (UV), or radio frequency. Ionizing radiation can be Alpha particles, Beta particles, Gamma rays, X-rays, high-speed electrons and protons and other atomic particles. These hazards can be found in radiology departments, nuclear medicine departments, laboratories, dental services, dietary, clinics, nurseries, surgical suites, and patient wards. Record Keeping/Posting Requirements - 29 CFR 1904 To provide employees with information regarding their rights under the OSH Act and provide a method of analyzing injury and illness trends. It also assists employers in their requirements for record keeping and posting of appropriate posters to comply with the OSH Act. Respiratory Protection - 29 CFR 1910.134 For the protection of employees from breathing air contaminated with dusts, fogs, fumes, gases, mists, smokes, sprays, and vapors. (This standard does not apply to TB) Respiratory Protection for TB - 29 CFR 1910.139 For the protection of employees from tuberculosis (TB). Violence in the Workplace - guideline To eliminate or reduce employee exposure to conditions that lead to death or injury in the workplace caused by the violence of another individual. Currently, there is no Code, other then the “General Duty Clause,” that directly addresses providing a workplace free of potential violence, and it only references by insinuation. Warning Signs - guideline To make those responsible for health care safety aware of the need to post warning signs to inform employees of certain potential dangers that they may face in the workplace. There is no specific regulation governing warning signs. The requirements are found within each regulation that requires them. Even though certain regulations do not require warning signs, each situation should be evaluated to determine if posting one would make for a safer environment. Waste Anesthetic Gases - guideline To protect employees from the hazards associated with exposure to waste anesthetic gases, including nitrous oxide, onflurane, halothane or other anesthetic gases. OSHA has not issued a specific standard for waste gases, but workplace inspectors will check for proper controls when conducting hospital safety inspections and exposure concerns can be cited under the General Duty Clause. Welding - 29 CFR 1910.252 To provide instructions in basic precautions for safety concerning welding, cutting, and brazing. Xylene - 29 CFR 1910.1000 To protect employees from exposure to xylene in the workplace. Xylene is typically used in laboratories and maintenance areas. Source: ASHE Healthcare Facilities Management Series document: Road Map to Health Care OSHA Compliance - prepared by the members of the South Carolina Health Alliance Occupational Safety and Health Administration (OSHA) Advisory Committee. Published by ASHE as Healthcare Facilities Number: 055166 - April 1999 Note: This is not an exhaustive list of all OSHA standards. For a complete listing of all OSHA Laws and Regulations go to www.osha.gov. Hospital eTool OSHA provides extensive compliance assistance. To help employers identify and address potential occupational hazards in hospitals, OSHA has developed a computerized graphical eTools. eTools are "stand-alone," interactive, Web-based training tools on occupational safety and health topics. They are highly illustrated and utilize graphical menus. Some also use expert system modules, which enable the user to answer questions, and receive reliable advice on how OSHA regulations apply to their work site. Using a graphical intuitive approach, Hospital eTool presents each potential hazard by the departments or services where it they could occur. For instance, clicking on Laundry opens a module which identifies potential risks (such as contaminated laundry, sharps handling, heat stress, and so on) and possible solutions. Although specific OSHA regulations are cited it does not read like stereo hookup instructions. Richly populated with photos and QuickTime video clips, Hospital eTool is an excellent resource for assessing your healthcare worker safety program. Hospital eTool is located at: www.osha.gov/SLTC/etools/hospital/index.html. Figure 6-1. Laws Empowering the EPA Law 1. Clean Air Act, 1970 2. Clean Water Act, 1977 (reauthorized 1987) 3. Toxic Substances Control Act, 1976 4. Resource Conservation and Recovery Act, 1976 5. Comprehensive Environmental Response, Compensation, and Liability Act, 1980 (also known as Superfund) 6. Superfund Amendments and Reauthorization Act, Allows EPA to: Set permissible levels for hazardous and visible emissions into the air. Limit discharge of pollutants into waterways. Set up the NPDES. Regulate manufacture, distribution, and use of toxic chemicals. Establish system by which wastes are tracked from "cradle to grave." Set aside funds for cleanup of contaminated waste sites. Broaden liability for contaminated sites. Reauthorize CERCLA. Establish system of response for environmental disasters. 1986 Source: Safety Guide for Health Care Institutions, 4th ed., published by American Hospital Publishing, Inc., copyright 1989, P. 23. Note: NPDES = National Pollutant Discharge Elimination System. Table 6-2. EPA Regional Offices Region Geographical Area Covered U.S. EPA Regional Office I Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont II New Jersey, New York, Puerto Rico, Virgin Islands III Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia IV Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Tennessee Carolina, Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin State Waste Programs Branch JFK Federal Building Boston, MA 02203 Air and Waste Management Division 26 Federal Plaza New York, NY 10278 Waste Management Branch MS 3HW 34 841 Chestnut Street Philadelphia, PA 19107 Hazardous Waste Management Division 345 Courtland Street, N.E. Atlanta, GA 30365 RCRA Activities Waste Management Division P0. Box A3587 Chicago, IL 60690 Air and Hazardous Materials Division 1201 Elm Street Inter-First Two Building Dallas, TX 75270 RCRA Branch 726 Minnesota Avenue Kansas City, KS 66620 Waste Management Division (8 HWM-ON) One Denver Place, Suite 1300 999 18th Street Denver, CO 80202-2413 Toxics and Waste Management Division 215 Fremont Street San Francisco, CA 94105 Waste Management Branch-MS-530 1200 Sixth Avenue Seattle, WA 98101 V VI Arkansas, Louisiana, New Mexico, Oklahoma, Texas VII Iowa, Kansas, Missouri, Nebraska Vlil Colorado, Montana, North Dakota, South Utah, Wyoming Dakota, IX Arizona, California, Hawaii, Nevada, American Samoa, Guam X Alaska, Idaho, Oregon, Washington Source: Safety Guide for Health Care Institutions, 4th ed., published by American Hospital Publishing, Inc., copyright 1989, P. 24. Table 6-3. Summary of Agencies and Voluntary Organizations and Their Scope Governmental Agency 1. Occupational Safety and Health Administration (OSHA) 2. U.S. Environmental Protection Agency (EPA) 3. Centers for Disease Control (CDC) 4. U.S. Food and Drug Administration (FDA) 5. U.S. Nuclear Regulatory Commission (NRC) 6. State and local agencies Scope Workplace safety and health Control of the release of harmful materials into the environment Control and prevention of disease Supervision of the development, testing, and monitoring of food, drugs, and medical devices The handling, use, and disposal of radiological materials Worker's compensation (many areas also covered by federal agencies) Voluntary Organization 1. Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) 2. National Fire Protection Agency (NFPA) 3. American National Standards Scope Institute (ANSI) Gas Association (CGA) 4. Compressed Services to users of compressed gases Standardization of practices to ensure high-quality patient care; accreditation Prevention of fire through standards and technical support Coordination and approval of standards Source: Safety Guide for Health Care Institutions, 4th ed., published by American Hospital Publishing, Inc., copyright 1989, P. 25. Parts of this chapter were reprinted, with permission, from Safety Guide for Health Care Institutions, 4th ed., published by American Hospital Publishing, Inc., copyright 1989. ________ ___ ACGI American Conference of Government Industrial Hygienists––A membership organization that benefits occupational health, provides technical information, and promotes excellence in environmental and occupational health. Developed the Threshold Limit Values for Chemical Substances. Also, publishes other documents related to industrial hygiene topics. ACM Asbestos-Containing Material––Materials that contain at least 1% asbestos. ANSI American National Standards Institute––A private organization that administrates and coordinates the U.S. private sector voluntary standardization system. ANSI does not develop standards, instead it facilitates development by establishing consensus among qualified groups. ASHRAE American Society of Heating, Refrigeration and Air Conditioning Engineers––A membership organization organized for the purpose of advancing the arts and sciences of heating, ventilation, air conditioning and refrigeration, for the public’s benefit, through writing standards, research, education and publication. CDC Center for Disease Control and Prevention––Promotes health and quality of life by preventing and controlling disease, injury, and disability. The CDC detects and investigates health problems, conducts research to enhance disease prevention, develops health policies, implements prevention strategies and fosters safe and healthy environments. CFR Code of Federal Regulations––A collection of federal laws issued under various “Titles.” Each Title contains laws relating to a specific agency of the U.S. Government. EPA Environmental Protection Agency––An agency established to protect human health and the natural environment, i.e., air, water, land. It develops and enforces federal laws regarding the release of harmful substances into the environment. IAQ Indoor air quality––The quality of breathable air within one’s work environment, including odors, carbon dioxide buildup, and pollutants. NFPA National Fire Protection Association––A membership organization that works to reduce fires through the advocation of scientifically based codes and standards, research and education for fire and related safety issues. NIOSH National Institute of Occupational Safety and Health––As a part of CDC, NIOSH is the only federal agency responsible for conducting research and making recommendations for the prevention of work-related illnesses and injury. OSHA Occupational Safety and Health Administration––As part of the U.S. Department of Labor, OSHA was established to save the lives, prevent injuries and protect the health of American workers. PEL Permissible exposure limits––The amount of specific air contaminant and the duration of employee exposure to that substance. PPE Personal protective equipment––Personal equipment worn by individuals for the protection against various hazards to which they are exposed in the workplace. RCRA Resource Conservation and Recovery Act––This federal law focuses on “cradle-to-grave” control of hazardous waste. Under RCRA, the EPA has authority to regulate underground storage tanks. SCBA Self-contained breathing apparatus––Respiratory protective device that utilizes its own oxygen. STEL Short-term exposure limits––Exposure based on a 15-minute period. TWA Time-weighted average––Eight-hour monitoring period based on a 40-hour work week.