What CMS' changes mean for medical gas system regulations

The Joint Commission has a working draft of new elements of performance for the medical gas and vacuum systems included in the environment of care section of the accreditation manual.

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Reliable medical gas and vacuum systems are at the pinnacle of patient care and provide critical sources of life-supporting gases that are required for proper treatment of patients in critical care areas of the hospital. The ongoing operation and maintenance of these systems for existing facilities is vital to ensuring that they remain safe and dependable for patients who rely on them for survival.

The Centers for Medicare & Medicaid Services (CMS) has affirmed that it will be requiring hospitals and health care facilities to meet the new conditions of participation, which include adherence to the 2012 edition of the National Fire Protection Association’s NFPA 99, Health Care Facilities Code. The Joint Commission and other accreditation agencies are following suit, and the Joint Commission has a working draft of new elements of performance for the medical gas and vacuum systems included in the environment of care section of the accreditation manual.

The Joint Commission has indicated that this update will provide for much more robust guidance on the standards for deemed status accreditation. This review of the medical gas and vacuum system requirements for existing facilities will help to explain the measures necessary to maintain compliance with the 2012 edition of NFPA 99, which will be crucial for maintaining accreditation starting next month.

Significantly different

The final version of NFPA 99, 2012 is significantly different from its predecessor, the 2005 edition. The document was upgraded from a standard to a code, while moving from occupancy-based to a risk-based approach of applying the requirements. The new code was developed over the course of seven years. Only a portion of this document was previously included in the requirements for meeting accreditation. Most of those in the industry know that the 1999 edition has been the law of the land for some time. The new edition undoubtedly will require facilities professionals to review and adapt to some critical changes.

In previous editions, the code generally had been applied to new or altered facilities, but it is clear that the 2012 edition is establishing the importance of maintenance and periodic testing of these systems. This edition of NFPA 99 will ensure that existing medical gas and vacuum systems remain safe and reliable on an ongoing basis and not just at the time of new construction.

Some of the requirements are essential for proper maintenance and operation of these systems in the health care environment. The following requirements for existing facilities, which include changes introduced in a Tentative Interim Amendment (TIA 12-4) released in March 2013 will have the greatest impact on the health care environment:

Nature of hazards (Section 5.1.2). This requirement is a basic understanding that all fire and explosion hazards and risks should be considered in any program developed for the operation and management of the medical gas and vacuum systems, including in the design, installation, testing, operation and maintenance of these systems. Since the NFPA was established in 1896, they have been publishing consensus codes and standards to assist with the elimination of these hazards and risks. The 2012 edition of NFPA 99 now helps to promote this in the existing health care facility and patient care environments.

System identification and labeling (Section 5.1.3.1). These requirements deal mostly with the labeling of high-pressure gas cylinders and cryogenic liquid containers. The labeling must be in accordance with nationally recognized standards, such as Department of Transportation regulations, the American Society of Mechanical Engineers’ Boiler and Pressure Vessel Code for Unfired Pressure Vessels, and many Compressed Gas Association standards, including requirements for cylinder labeling, gas-specific outlet connections and cylinder content verification procedures. Not to be missed in this section is a very prescriptive requirement for doorway labeling of locations containing central supply systems and cylinder storage.

Central supply system operations (Section 5.1.3.2). This section discusses the use and handling of gas cylinders and cryogenic liquid containers. It includes appropriate conditions to ensure that the cylinders and containers are not exposed to potentially hazardous environments. There is a requirement for only gas cylinders, reusable shipping containers and cylinder accessories to be stored in rooms containing central supply systems or gas cylinders. Another prohibits storing flammable materials, cylinders containing flammable gases and other flammable liquids with gas cylinders. This section disallows the use of adapters or conversion fittings to adapt from one gas-specific fitting to another. This is meant to eliminate the chance of cross-connections causing the wrong gas to be administered to a patient, which is one of the major causes of accidental deaths with medical gas systems.

Cylinder temperature (Sections 5.1.3.3.1.7 and 5.1.3.3.1.8). These paragraphs outline the temperature requirements for cylinders that are both in use and in storage. These cylinders shall be prevented from reaching temperatures in excess of 130 F, and central supply systems for nitrous oxide and carbon dioxide shall be prevented from reaching in excess of 125 F and never less than negative 20 F. This is because these two gases exist as a liquid in the cylinder at room temperature and the vaporization rate significantly diminishes at lower temperatures, which can cause the supply systems to malfunction or possibly fail.

Cylinder storage (Section 5.1.3.3.4). This section undoubtedly will be the most controversial due to the impact on existing cylinder storage locations. All full or empty medical gas cylinders, when not connected, shall be stored in locations complying with 5.1.3.3.2 through 5.1.3.3.3. This portion of the code provides guidance on the design and construction of locations used for central supply systems and the storage of positive-pressure gases. These are the standard requirements for a manifold or cylinder storage room or enclosure. These locations must be locked or otherwise secured, have electrical devices protected from physical damage and be provided with appropriate racks, chains or other fastenings to secure cylinders from falling. If the location is outdoors, it must have a minimum of two entries and exits. If the location is indoors, it must have interior finishes that are noncombustible or include limited combustible materials and have a minimum one-hour fire rating for all walls, floors, ceilings and doors.

Because the phrase, “when not connected” is used in the requirement, it appears the intent of the section is to apply only to the cylinders stored for use with manifold central supply systems and it would not pertain to cylinders in storage for direct patient use (i.e. “E” type cylinders used for temporary support like patient transport). This is further justified by the guidance provided in the Gas Equipment chapter (Section 11.3).

Chapter 11 outlines the requirements for cylinder and container storage for the clinical use of high-pressure cylinders for direct patient care or support. The requirements include that storage locations containing greater than 3,000 cubic feet of gas shall comply with the design and construction requirements identified previously. Also, locations storing gases greater than 300, but less than 3,000 cubic feet must be in an outdoor enclosure or an enclosed interior space of noncombustible or limited combustible construction and have doors or gates that can be secured against unauthorized entry. Further, oxidizing gases shall not be stored with flammable gas, liquid or vapors. They also must be separated from combustible materials with a minimum distance of 20 feet — or 5 feet if the area is protected by an automatic sprinkler system. This quantity of gas also is allowed to be stored in an enclosed cabinet that has a fire protection rating of a half-hour.

Use of medical air (Section 5.1.3.6.2). This section has not changed in the code for a very long time. However, because it now comes under the requirements for existing facilities, it should be highlighted for a couple of reasons. First, this requirement is to prevent the use of medical air systems for any purpose other than for human respiration or the calibration of medical devices for respiratory applications. The well-documented uses of medical air for purposes other than these include processing instruments or tools after sterilization, powering shop or maintenance air tools (i.e., “shop air”), laboratory air applications and many other noncompliant uses.

One reason for the confusion is because many of the standards for other support functions in the facility that require clean compressed air make reference to “medical-grade” air. This confusion has led some facilities to use the medical air for purposes that are clearly not allowed. This requirement is to prevent the possibility of contaminating these critical systems, which are used by patients who are the most reliant on clinical staff and these systems for survival.

Waste anesthetic gas disposal (Section 5.1.3.8.5.2). TIA 12-4, which is discussed previously, appears to be incorrect with regard to this section. (This is not an official NFPA clarification, but is the author’s understanding based on the discussions that took place during the TIA process. At the time of this writing, there is another TIA request in process to correct this item.) The reference in the TIA is for a requirement that the waste anesthetic gas disposal (WAGD) producers must have manual or automatic alternation and that a scheduled switchover is needed if the producers are operated with manual alternation. This requirement is true of all motorized medical gas equipment and seems odd that it was pulled out specifically for existing WAGD systems.

The author’s understanding is that the reference should have been 5.1.3.8.1.2, which is a new requirement for WAGD systems that are combined with medical vacuum sources. This section mandates that if the systems are combined, the total concentration of oxidizing gases (oxygen and nitrous oxide) shall be maintained below 23.6 percent. This percentage would keep the concentration below the defined level of an “oxidizer or oxygen-enriched” environment. If this level cannot be maintained, then it would require that the vacuum pumps comply with those used exclusively for WAGD systems. WAGD-specific pumps are designed using materials and lubricants that are inert in the presence of oxygen, nitrous oxide and halogenated anesthetics.

The bottom line is to prevent fires in vacuum pumps that are not designed to be used with oxidizing gases. Because there have been fires due to this condition, the requirement was introduced to reduce the chances of a fire when combining these systems.

Operation and management (Section 5.1.14 and 5.1.15). These sections of the code have seen the most significant changes and probably will impact facilities professionals the most. There are new requirements for developing and documenting a comprehensive maintenance, inspection and testing program for existing medical gas and vacuum systems and their subcomponents.

A maintenance program complete with inventories, inspection and maintenance schedules, and inspection and maintenance procedures must be developed through a risk assessment conducted by the facility with consideration given to the original equipment manufacturer’s recommendations. The frequency of some of these items are defined in NFPA 99 and others are left up to the facility for determination. Because procedures for these tasks must be documented, they can either be industry-accepted best practices or as determined by the facility through a risk assessment.

Another expectation is that individuals maintaining these systems must be qualified to perform these operations. Appropriate qualification must be demonstrated through one of three options. These include a documented training and certification program through the health care facility by which the individual is employed, or with either an American Society of Sanitary Engineers (ASSE) 6030 Medical Gas Systems Verifier Certification or an ASSE 6040 Medical Gas Systems Maintenance Personnel Certification. These qualifications indicate that an individual has demonstrated that he or she is trained and technically competent to perform this work.

Importance of systems

These requirements illustrate the importance that is being placed on working with and maintaining medical gas and vacuum systems.

The requirements for existing facilities is beginning to trend toward increasing dependability of these systems on an ongoing basis.

Developing and implementing a comprehensive operation and management program for these critical systems is the best way to ensure that they remain safe and reliable for patients, personnel and visitors in health care facilities.  HFM

Jonathan C. Willard, CPD, CHC, PMP, CMGV, is the president of Acute Medical Gas Services Inc., Manchester, N.H., specializing in comprehensive medical gas services, consulting, training and regulatory compliance. He is a principal member of the NFPA’s technical committee on medical gas and vacuum piping systems for NFPA 99, Health Care Facilities Code, and a principal member of the technical committee on industrial and medical gases for NFPA 55, Compressed Gases and Cryogenic Fluids Code. He can be reached at jon@acutemedgas.com. This article provides a general description of regulatory requirements and does not constitute legal advice.