CoP Physical Environment
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A-0700 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.
Interpretive Guidelines §482.41
This CoP applies to all locations of the hospital, all campuses, all satellites, all provider-based activities, and all inpatient and outpatient locations.
The hospital’s Facility Maintenance and hospital departments or services responsible for the hospital’s buildings and equipment (both facility equipment and patient care equipment) must be incorporated into the hospital’s QAPI program and be in compliance with the QAPI requirements.
A-0701 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured.
Interpretive Guidelines §482.41(a)
The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner to ensure the safety and well-being of patients. This includes ensuring that routine and preventive maintenance and testing activities are performed as necessary, in accordance with Federal and State laws, regulations, and guidelines and manufacturer’s recommendations, by establishing maintenance schedules and conducting ongoing maintenance inspections to identify areas or equipment in need of repair. The routine and preventive maintenance and testing activities should be incorporated into the hospital’s QAPI plan.
The hospital must be constructed and maintained to ensure risks are minimized for patients as well as for employees and visitors. Hospitals are expected to demonstrate how they are addressing important safety features in accordance with nationally recognized standards. Although the following items are expected to be addressed when applicable, the list is not all-inclusive.
• The hospital must ensure all buildings at all locations of the certified hospital meet State and Federal accessibility standards (e.g. Office of Civil Rights requirements). The requirements apply to the interior and exterior of all buildings.
Age-related safety features
• Hospitals are expected to address safety hazards and risks related to age-related factors. Healthcare provided to neonatal, pediatric, and geriatric patients must be in accordance with nationally recognized standards. Age-related risks may include items such as security of inpatient and outpatient locations, access to medications, cleaning supplies and other hazardous materials, furniture and other medical equipment, and increased chance of falls.
• To minimize the risk of unauthorized access to or inappropriate departure from secured healthcare units, hospitals must demonstrate security features in accordance with nationally recognized standards to ensure the safety of vulnerable patients. This includes, but is not limited to, patients such as newborn (e.g. infant abduction), pediatric, behavioral health, those with diminished capacity and dementia/Alzheimer’s.
Access to non-clinical rooms identified as hazardous locations must be secured to prevent patient and visitor entry. Examples include electrical rooms and heat, ventilation, air conditioning (HVAC) rooms.
• The presence of unmitigated ligature risks in a psychiatric hospital or psychiatric unit of a hospital is an immediate jeopardy situation. Additionally, this also includes any location where patients at risk of suicide are identified. Ligature risk findings must be referred to the health and safety surveyors for further evaluation and possible citation under Patients’ Rights.
Weather-related exterior issues
• Although hospitals cannot address all weather-related issues, they are expected to address potential safety hazards specific to weather on both the exterior and interior locations in accordance of nationally recognized standards. Areas of risk include driveways, garages, entry points, walkways, etc.
Life Safety Code surveyors assess the use of power strips in healthcare facilities. However, the following guidance is provided as reference for healthcare surveyors as they survey physical environment along with other CoP requirements. Any observed power strip deficiencies should be conveyed to the LSC surveyors for citation.
If line-operated medical equipment is used in a patient care room/area, inside the patient care vicinity:
• UL power strips would have to be a permanent component of a rack-, table-, pedestal-, or cart-mounted & tested medical equipment assembly
• Power strips providing power to medical equipment in a patient care room/area must be UL 1363A or UL 60601-1
• Power strips cannot be used for non-medical equipment
If line-operated medical equipment is used in a patient care room/area, outside the patient care vicinity:
• UL power strips could be used for medical & non-medical equipment with
precautions as described in the memo
• Power strips providing power to medical equipment in a patient care room/area must be UL 1363A or UL 60601-1
• Power strips providing power to non-medical equipment in a patient care room/area must be UL 1363
If line-operated medical equipment is not used in a patient care room/area, inside and outside the patient care vicinity:
• UL power strips could be used with precautions
Power strips providing power to non-medical equipment in a patient care room/area must be UL 1363. In non-patient care areas/rooms, other UL strips could be used with the general precautions.
A-0702 482.41(a)(1) There must be emergency power and lighting in at least the operating, recovery, intensive care, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available.
Interpretive Guidelines §482.41(a)(1)
The hospital must comply with the applicable provisions of the Life Safety Code, National Fire Protection Amendments (NFPA) 101, 2000 Edition and applicable references, such as, NFPA-99: Health Care Facilities, for emergency lighting and emergency power.
A-703 482.41(a)(2) There must be facilities for emergency gas and water supply.
Interpretive Guidelines §482.41(a)(2)
The hospital must have a system to provide emergency gas and water as needed to provide care to inpatients and other persons who may come to the hospital in need of care. This includes making arrangements with local utility companies and others for the provision of emergency sources of water and gas. The hospital should consider nationally accepted references or calculations made by qualified staff when determining the need for at least water and gas. For example, one source for information on water is the Federal Emergency Management Agency (FEMA).
Emergency gas includes fuels such as propane, natural gas, fuel oil, liquefied natural gas, as well as any gases the hospital uses in the care of patients such as oxygen, nitrogen, nitrous oxide, etc.
The hospital should have a plan to protect these limited emergency supplies, and have a plan for prioritizing their use until adequate supplies are available. The plan should also address the event of a disruption in supply (e.g., disruption to the entire surrounding community).
A-0709 482.41(b) The hospital must ensure that the life safety from fire requirements are met.
No information available.
A-0710 482.41(b)(1) Except as otherwise provided in this section:
(i) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101®2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register to announce the changes.
(ii) Chapter 22.214.171.124.2, exception number 2 of the adopted edition of the LSC does not apply to hospitals.
(2) After consideration of State survey agency findings, CMS may waive specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon the facility, but only if the waiver does not adversely affect the health and safety of the patients.
(3) The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire and safety code imposed by State law adequately protects patients
Interpretive Guidelines §482.41(b)(1) –(3)
Medicare-participating hospitals, regardless of size or number of beds, must comply with the hospital/healthcare Life Safety Code requirements for all inpatient care locations. Hospital departments and locations such as emergency departments, outpatient care locations, etc. must comply with hospital/healthcare Life Safety Code Requirements. Additionally, the hospital must be in compliance with all applicable codes referenced in the Life Safety Code, such as, NFPA-99: Health Care Facilities.
Life Safety Code waivers may be recommended by the State survey agency but only CMS (at the Regional Office level) may grant those waivers for Medicare or Medicaid-participating hospitals.
A-0711 482.41(b)(4) Beginning March 13, 2006, a hospital must be in compliance with Chapter 19.2.9, Emergency Lighting.
Interpretive Guidelines §482.41(b)(4)
Beginning March 13, 2006, Medicare-participating hospitals must be in compliance with Chapter 19.2.9 of the 2000 Edition of NFPA 101. Hospitals have until that date to replace 1-hour batteries with 1-1/2 hour batteries in emergency lighting systems that use batteries as power sources. After March 13, 2006, a hospital with emergency lighting systems with less than 1-1/2 hour batteries will not be in compliance and will be cited.
A-0712 482.41(b)(5) Beginning March 13, 2006, Chapter 126.96.36.199.2, exception number 2 does not apply to hospitals.
Interpretive Guidelines §482.41(b)(5)
Beginning March 13, 2006, Medicare-participating hospitals may not keep in service roller latches even when those roller latches are demonstrating the ability to keep the door closed against 5lbf. A hospital with doors in service that have roller latches, where positive latching is required, will not be in compliance and will be cited.
A-0713 482.41(b)(6) The hospital must have procedures for the proper routine storage and prompt disposal of trash.
Interpretive Guidelines §482.41(b)(6)
The term trash refers to common garbage as well as biohazardous waste. The storage and disposal of trash must be in accordance with Federal, State and local laws and regulations (i.e., EPA, OSHA, CDC, State environmental, health and safety regulations). The Conditions of Participation for Radiology and Nuclear Medicine Services address handling and storage of radioactive materials.
A-0714 482.41(b)(7) The hospital must have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients,
personnel and guests; evacuation; and cooperation with fire fighting authorities.
No information available.
A-0715 482.41(b)(8) The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies.
No information available.
A-0716 482.41(b)(9) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a hospital may install alcohol-based hand rub dispensers in its facility if:
(i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;
(ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately protects against inappropriate access; and
(iv) The dispensers are installed in accordance with Chapter 188.8.131.52 or Chapter 184.108.40.206 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00–1(101), issued by the Standards
Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00–1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269.
(v) The dispensers are maintained in accordance with dispenser manufacturer guidelines.
Interpretive Guidelines, 482.41(b)(9):
CMS amended its regulations, following an NFPA LSC amendment to permit the installation of alcohol-based hand run (ABHR) dispensers in exit access corridors of health care facilities. Previously, ABHR dispensers had been permitted in patient rooms, but not in egress corridors, since they contain flammable materials and could block egress in a fire.
ABHR dispensers have become increasingly common as an infection control method. Healthcare-acquired infections are of increasing concern, and many such infections are transmitted because health care workers do not wash their hands or do so improperly or inadequately.
An important aspect of getting health care workers to use ABHR dispensers is their accessibility. The American Hospital Association commissioned a study to determine the safest method to place ABHR dispensers in egress corridors. As a result of this study, the LSC was amended to permit their use under certain conditions, and CMS has adopted this change in its regulations.
Regular maintenance is seen as a crucial step in making sure that dispensers neither leak nor the contents spill. Hospitals are expected to maintain ABHR dispensers in accordance with manufacturers’ guidelines. If the manufacturer does not have specific maintenance requirements, the facility is expected to develop its own policies and procedures to ensure that the dispensers neither leak nor the contents spill.
A-0722 482.41(c) The hospital must maintain adequate facilities for its services.
Interpretive Guidelines §482.41(c)
Adequate facilities means the hospital has facilities that are:
• Designed and maintained in accordance with Federal, State and local laws, regulations and guidelines; and
• Designed and maintained to reflect the scope and complexity of the services it offers in accordance with accepted standards of practice.
A-0723 482.41(c)(1) Diagnostic and therapeutic facilities must be located for the safety of patients.
Interpretive Guidelines §482.41(c)(1)
Diagnostic and therapeutic facilities must be in rooms or areas specifically designed for the purpose intended.
A-0724 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.
Interpretive Guidelines §482.41(c)(2)
The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner that provides an acceptable level of safety and well-being of patients, staff and visitors.
The hospital must ensure that supplies are maintained to provide an acceptable level of safety and quality for patients. Among other things, this means that the hospital identifies the supplies required to meet its patients’ needs for both day-to-day operations as well as those supplies that are likely to be needed in likely emergency situations, such as mass casualty events resulting from natural disasters, mass trauma, disease outbreaks, etc. Further, the hospital must make adequate provisions to ensure the availability of those supplies when needed.
Supplies must be stored in such a manner to ensure their safety (protection against theft or damage, contamination, or deterioration), as well as that the storage practices do not violate fire codes or otherwise endanger patients (storage of flammables, blocking passageways, storage of contaminated or dangerous materials, safe storage practices for poisons, etc.).
In order to ensure an acceptable level of safety and quality, the hospital must identify the equipment required to meet its patients’ needs for both day-to-day operations and in a likely emergency/disaster situation, such as mass casualty events resulting from natural disasters, mass trauma, disease outbreaks, internal disasters, etc. In addition, the hospital must make adequate provisions to ensure the availability and reliability of equipment needed for its operations and services. Equipment includes both facility equipment, which supports the physical environment of the hospital (e.g., elevators, generators, air handlers, medical gas systems, air compressors and vacuum systems, etc.) and medical equipment, which are devices intended to be used for diagnostic, therapeutic or monitoring care provided to a patient by the hospital (e.g., IV infusion equipment, ventilators, laboratory equipment, surgical devices, etc.).
All equipment must be inspected and tested for performance and safety before initial use
and after major repairs or upgrades.
All equipment must be inspected, tested, and maintained to ensure their safety, availability and reliability. Equipment maintenance activities may be conducted using hospital personnel, contracted services, or through a combination of hospital personnel and contracted services. Individual(s) responsible for overseeing the development, implementation, and management of equipment maintenance programs and activities must be qualified. The hospital maintains records of hospital personnel qualifications and is able to demonstrate how it assures all personnel, including contracted personnel, are qualified.
All equipment maintenance policies, procedures and programs, as well as specific equipment maintenance inventories, activities and schedules, fall under the purview of the hospital’s clinical maintenance personnel, safety department personnel or other personnel who have been assigned responsibility for equipment maintenance by hospital leadership.
Hospitals comply with this regulation when they follow the manufacturer-recommended maintenance activities and schedule. Hospitals may choose to perform maintenance more frequently than the manufacturer recommends, but must use the manufacturer-recommended maintenance activities in such cases. When equipment is maintained in accordance with the manufacturer’s recommendations, the hospital must maintain documentation of those recommendations and the hospital’s associated maintenance activity for the affected equipment.
Alternate Equipment Management (AEM) Program
A hospital may, under certain conditions, use equipment maintenance activities and frequencies that differ from those recommended by the manufacturer. Hospitals that choose to employ alternate maintenance activities and/or schedules must develop, implement, and maintain a documented AEM program to minimize risks to patients and others in the hospital associated with the use of facility or medical equipment. The AEM program must be based on generally accepted standards of practice for facility or medical equipment maintenance. An example of guidelines for a medical equipment medical equipment maintenance program may be found in the American National Standards Institute/ Association for the Advancement of Medical Instrumentation document: ANSI/AAMI EQ 56:1999/ (R) 2013, Recommended Practice for a Medical Equipment Management Program. Likewise, an example of guidelines for physical plant equipment may be found in the American Society for Healthcare Engineering (ASHE) 2009 document: Maintenance Management for Health Care Facilities. There may be similar documents issued by other nationally recognized organizations which hospitals might choose to reference.
Decision to Place Equipment in an AEM Program
The determination of whether it is safe to perform facility or medical equipment maintenance without following the equipment manufacturer recommendations must be made by qualified personnel, regardless of whether they are hospital employees or contractors.
In the case of medical equipment, a clinical or biomedical technician or engineer would be considered qualified. Highly specialized or complex equipment may require specialized knowledge or training in order for personnel to be considered qualified to make a decision to place such equipment in an AEM program.
In the case of facility equipment, a Healthcare Facility Management professional (facility manager, director of facilities, vice president of facilities) would be considered qualified.
The hospital must maintain records of the qualifications of hospital personnel who make decisions on placing equipment in an AEM program, and must be able to demonstrate how they assure contracted personnel making such decisions are qualified.
In determining whether or not to include equipment in an AEM program, and which maintenance strategies to use in developing maintenance activities and frequencies for particular equipment, the hospital must take into account the typical health and safety risks associated with the equipment’s use. Note that the risk may vary for the same type of equipment, depending on the patient care setting within the hospital where it is used.
A hospital is expected to identify any equipment in its AEM program which is “critical equipment,” i.e., biomedical or physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail. Surveyors must focus their review of a hospital’s AEM program on critical equipment in that program and the hospital’s documentation of the factors and evidence it considered in developing an AEM strategy for that equipment.
Factors for a hospital to consider when evaluating the risks associated with a particular type of equipment include, but are not limited to:
• How the equipment is used and the likely consequences of equipment failure or malfunction - would failure or malfunction of the equipment hospital-wide or in a particular setting be likely to cause harm to a patient or a staff person?
• How serious is the harm likely to be? For example, a slightly miscalibrated scale in an adult internal medicine outpatient clinic might not present significant risk of harm. However, a miscalibrated scale in a neonatal intensive care unit could have very serious consequences for patient care.
• How widespread is the harm likely to be? For example, are many patients exposed to the equipment, resulting in harm due to failure impacting more patients or staff? If harm would be widespread, even if the harm to each affected individual is not serious, this would be a cause for concern.
• Information, if available, on the manufacturer’s equipment maintenance recommendations, including the rationale for the manufacturer’s recommendations;
• Maintenance requirements of the equipment:
• Are they simple or complex?
• Are the manufacturer’s instructions and procedures available in the hospital, and if so can the hospital explain how and why it is modifying the manufacturer’s instructions?
• If the manufacturer’s instructions are not available in the hospital, how does the hospital assess whether the AEM uses appropriate maintenance strategies?
• How readily can the hospital validate the effectiveness of AEM methods for particular equipment? For example, can the hospital explain how it ensures there is no reduction in the quality of the performance of biomedical equipment subjected to alternate maintenance methods?
• The timely availability of alternate devices or backup systems in the event of equipment failure or malfunction; and
• Incident history of identical or very similar equipment – is there documented evidence, based on the experience of the hospital (or its third party contractor), or on evidence publicly reported by credible sources outside the hospital, which:
• Provides the number, frequency and nature of previous failures and service requests?
• Indicates use of an AEM strategy does not result in degraded performance of the equipment?
Generally multiple factors must be considered, since different types of equipment present different combinations of severity of potential harm and likelihood of failure. The hospital is expected to be able to demonstrate to a surveyor the factors it considered in its risk assessment for equipment placed in its AEM program.
Equipment not Eligible for Placement in the AEM Program:
Some equipment may not be eligible for placement in the AEM program, for one or more of the following reasons:
• Other Federal law (for example, regulations promulgated by another Federal agency)
or State law may require that facility or medical equipment maintenance, inspection and testing be performed strictly in accordance with the manufacturer’s recommendations, or may establish other, more stringent maintenance requirements. In these instances, the hospital must comply with these other Federal or State requirements, but State Surveyors conducting Federal surveys assess compliance only with the hospital Conditions of Participation (CoPs).
• Other CoPs require adherence to manufacturer’s recommendations and/or set specific standards which preclude their inclusion in an AEM program. For example:
• The National Fire Protection Association Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance, and compliance with these requirements are assessed on Federal surveys. Further, §482.41(b)(9)(v) requires hospitals to adhere to the manufacturer’s maintenance guidelines for alcohol-based hand-rub dispensers. Compliance with these requirements is assessed on Federal surveys.
• Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by 42 CFR 482.26(b)(2) and must be maintained per manufacturer’s recommendations.
• The equipment is a medical laser device. It should be noted that for medical lasers the U.S. Food and Drug Administration requires manufacturers to provide a schedule of maintenance and adequate instructions for service adjustments and service procedures to purchasers and, at cost, to any other parties requesting them.
• New equipment for which sufficient maintenance history, either based on the hospital’s own or its contractor’s records, or available publicly from nationally recognized sources, is not available to support a risk-based determination must not be immediately included in the AEM program. New equipment must be maintained in accordance with manufacturer recommendations until a sufficient amount of maintenance history has been acquired to determine whether the alteration of maintenance activities or frequencies would be safe. If a hospital later transitions the equipment to a risk-based maintenance regimen different than the manufacturers’ recommendations, the hospital must maintain evidence that it has first evaluated the maintenance track record, risks, and tested the alternate regimen.
Alternative Maintenance Frequencies or Activities
Maintenance strategies are various methodologies used for determining the most efficient and effective maintenance activities and frequencies. Manufacturers’ recommendations may be based on one or more such strategies. A hospital may also use one or more maintenance strategies for its AEM program in order to determine the appropriate maintenance, inspection, and testing activities and frequencies, based upon the nature of
the equipment and the level of risk it presents to patient or staff health and safety. The risk to patient health and safety that is considered in developing alternative maintenance strategies must be explained and documented in the AEM program.
In developing AEM maintenance strategies hospitals may rely upon information from a variety of sources, including, but not limited to: manufacturer recommendations and other materials, nationally recognized expert associations, and/or the hospital’s (or its third party contractor’s) own experience. Maintenance strategies may be applied to groups or to individual pieces of equipment.
The hospital is expected to adhere strictly to the AEM activities or strategies it has developed.
Background Information on Types of Maintenance Strategies
• Preventive Maintenance (Time-based Maintenance) – a maintenance strategy where maintenance activities are performed at scheduled time intervals to minimize equipment degradation and reduce instances where there is a loss of performance. Most preventive maintenance is “interval-based maintenance” performed at fixed time intervals (e.g., annual or semi-annual), but may also be “metered maintenance” performed according to metered usage of the equipment (e.g., hours of operation). In either case, the primary focus of preventive maintenance is reliability, not optimization of cost-effectiveness. Maintenance is performed systematically, regardless of whether or not it is needed at the time. Example: Replacing a battery every year, after a set number of uses or after running for a set number of hours, regardless.
• Predictive Maintenance (Condition-based Maintenance) – a maintenance strategy that involves periodic or continuous equipment condition monitoring to detect the onset of equipment degradation. This information is used to predict future maintenance requirements and to schedule maintenance at a time just before equipment experiences a loss of performance. Example: Replacing a battery one year after the manufacturer’s recommended replacement interval, based on historical monitoring that has determined the battery capacity does not tend to fall below the required performance threshold before this extended time.
• Reactive Maintenance (Corrective, Breakdown or Run-to-Failure Maintenance) – a maintenance strategy based upon a “run it until it breaks” philosophy, where maintenance or replacement is performed only after equipment fails or experiences a problem. This strategy may be acceptable for equipment that is disposable or low cost, and presents little or no risk to health and safety if it fails. Example: Replacing a battery after equipment failure when the equipment has little negative health and safety consequences associated with a failure and there is a replacement readily available in supply.
• Reliability-Centered Maintenance – a maintenance strategy that not only considers equipment condition, but also considers other factors unique to individual pieces of equipment, such as equipment function, consequences of equipment failure, and the operational environment. Maintenance is performed to optimize reliability and cost effectiveness. Example: Replacing a battery in an ambulance defibrillator more frequently than the same model used at a nursing station, since the one in the ambulance is used more frequently and is charged by an unstable power supply.
Tools (e.g., hand tools, test equipment, software, etc.) necessary for performing equipment maintenance must be available and maintained to ensure that measurements are reliable. Tools used for maintenance are not required to be those specifically recommended by the manufacturer, but tools utilized must be capable of providing results equivalent to those required by the equipment manufacturer.
AEM Program Documentation
For each type of equipment subject to the AEM program, there must be documentation indicating:
• The pertinent types and level of risks to patient or staff health and safety;
• Alternate maintenance activities, and the maintenance strategy and any other rationale used to determine those activities; the differences from the manufacturer’s recommended maintenance activities are made explicit, unless the hospital is unable to obtain the manufacturer’s maintenance recommendations, due to the age of the equipment or the manufacturer’s restricting the availability of its recommendations;
• Alternate maintenance frequencies to be used, if any, and the maintenance strategy and any other rationale used to determine those frequencies. For equipment identified as presenting a very low risk to patient or staff safety, it could be acceptable to not set a particular frequency but instead indicate a less specific approach, for example, an interval range, such as “every 12 – 24 months.” It could also be acceptable to employ periodic “departmental sweeps” for such very low risk equipment, where equipment functioning is sampled and operators are polled about its functionality.
• The date when AEM program maintenance activities were performed and, if applicable, further actions required/taken; and
• Documentation of any equipment failures (not including failures due to operator error), including whether there was resulting harm to an individual. (Note: equipment failure that is due to operator error and which results in an adverse event or near miss must be documented in accordance with the QAPI CoP, as part of the hospital’s required tracking of patient safety-related incidents. However, there is no
requirement to include operator failures in equipment maintenance documentation.)
When the hospital has multiple identical equipment items, the documentation may be generic to that type of equipment, except that documentation of maintenance activities performed must be specific to each item of equipment.
Evaluating Safety and Effectiveness of the AEM Program
The hospital must have policies and procedures which address the effectiveness of its AEM program. In evaluating the effectiveness of the AEM program the hospital is expected to address factors including, but not limited to:
• How equipment is evaluated to ensure there is no degradation of performance, particularly for equipment where such degradation may not be readily apparent to staff using the equipment, e.g., miscalibration.
• How incidents of equipment malfunction are investigated, including:
• whether or not the malfunction could have been prevented, and what steps will be taken to prevent future malfunctions; and
• how a determination is made whether or not the malfunction resulted from the use of an AEM strategy;
• The process for the removal from service of equipment determined to be unsafe or no longer suitable for its intended application; and
• The use of performance data to determine if modifications in the AEM program procedures are required.
All hospital facility and medical equipment, regardless of whether it is leased or owned, and regardless of whether it is maintained according to manufacturer recommendations or is in an AEM program, is expected to be listed in an inventory which includes a record of maintenance activities. For low cost/low risk equipment, such as housekeeping cleaning equipment, it is acceptable for the inventory to indicate under one item the number of such pieces of equipment in the hospital, e.g., “15 vacuum cleaners for cleaning patient rooms and common areas.”
If the hospital is using an AEM program, the equipment managed through that program must be readily separately identifiable as subject to AEM. Critical equipment, whether in an AEM program or not, must also be readily identified as such.
To facilitate effective management, a well-designed equipment inventory contains the
following information for all equipment included. However, hospitals have the flexibility to demonstrate how alternative means they use are effective in enabling them to manage their equipment.
• A unique identification number;
• The equipment manufacturer;
• The equipment model number;
• The equipment serial number;
• A description of the equipment;
• The location of the equipment (for equipment generally kept in a fixed location);
• The identity of the department considered to “own” the equipment;
• Identification of the service provider;
• The acceptance date; and
• Any additional information the hospital believes may be useful for proper management of the equipment.
A-0725 482.41(c)(3) The extent and complexity of facilities must be determined by the services offered.
Interpretive Guidelines §482.41(c)(3)
Physical facilities must be large enough, numerous enough, appropriately designed and equipped, and of appropriate complexity to provide the services offered in accordance with Federal and State laws, regulations and guidelines and accepted standards of practice for that location or service.
A-0726 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas.
Interpretive Guidelines §482.41(c)(4)
There must be proper ventilation in at least the following areas:
• Areas using ethylene oxide, nitrous oxide, guteraldehydes, xylene, pentamidine, or other potentially hazardous substances;
• Locations where oxygen is transferred from one container to another;
• Isolation rooms and reverse isolation rooms (both must be in compliance with Federal and State laws, regulations, and guidelines such as OSHA, CDC, NIH, etc.);
• Pharmaceutical preparation areas (hoods, cabinets, etc.);
• Laboratory locations; and
• Anesthetizing locations. According to NFPA 99, anesthetizing locations are “Any area of a facility that has been designated to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment, including the use of such agents for relative analgesia.” NFPA 99 defines relative analgesia as “A state of sedation and partial block of pain perception produced in a patient by the inhalation of concentrations of nitrous oxide insufficient to produce loss of consciousness (conscious sedation).” (Note that this definition is applicable only for LSC purposes and does not supercede other guidance we have issued for other purposes concerning anesthesia and analgesia.)
There must be adequate lighting in all the patient care areas, and food and medication preparation areas. Temperature, humidity and airflow in anesthetizing locations must be maintained within acceptable standards to inhibit microbial growth, reduce risk of infection, control odor, and promote patient comfort. Hospitals must maintain relative humidity (RH) levels at 35 percent or greater in each anesthetizing location, unless the hospital elects to use the CMS categorical waiver, which permits it to maintain a RH of at least 20 percent (see Appendix I, Section II for additional information). Hospitals must maintain records that demonstrate they have achieved the required levels. Although not required, CMS recommends that hospitals maintain the upper range of RH at 60 percent or less, as excessive humidity is conducive to microbial growth and compromises the integrity of wrapped sterile instruments and supplies. Each operating room should have separate temperature control. Acceptable standards such as from the Association of Operating Room Nurses (AORN) or the Facilities Guidelines Institute (FGI) should be incorporated into hospital policy.
The hospital must ensure that an appropriate number of refrigerators and/or heating devices are provided and ensure that food and pharmaceuticals are stored properly and in accordance with nationally accepted guidelines (food) and manufacturer’s recommendations (pharmaceuticals).