Download Chapter 6

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.