COPYRIGHT © 2015, ALL RIGHTS RESERVED.

COPYRIGHT © 2015, ALL RIGHTS RESERVED.
 NFPA 99: Health Care Facilities Code Changes in the Medical Gas and Vacuum System Requirements NFPA 99, 2015 Edition. PRESENTED BY: Jonathan C. Willard, CPD, CMGV, LEED AP, CHC, PMP Acute Medical Gas Services, Inc. Manchester, New Hampshire COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Introduction Jonathan C. Willard, Compliance Specialist Medical Gas and Healthcare Construction for 20 Years ASSE 6000 Medical Gas Professional Certifications and MGPHO Credentialed Medical Gas Verifier Principal Member of Technical Committee on Medical Gas and Vacuum Piping Systems (NFPA 99) & Technical Committee on Industrial and Medical Gases (NFPA 55) Served on the Medical Gas Professional Healthcare Organization (MGPHO) Board of Directors Certified in Plumbing Design (CPD), Certified Healthcare Constructor (CHC) & Project Management Professional (PMP), LEED Accredited Professional (LEED AP) Company has roots in the Medical Gas Industry since 1978 COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

Our Organization has roots in New England since 1978!
Assisting Healthcare Facilities with their medical gas and environmental testing needs for OVER 35 YEARS. Compliance / Consulting Certifications / Verifications  Periodic Inspections and Testing  Environmental Testing Equipment Service (24 Hour) Preventative Maintenance Training COPYRIGHT © 2015, ALL RIGHTS RESERVED.

Third-Party Certification Agency (ANSI Standards) Nationally Recognized Program Approvals Throughout the US and Internationally Administers the ASSE 6000 Certification Programs Certified Instructors (Regionally Located) Online Training Programs and Re-Certification Programs COPYRIGHT © 2015, ALL RIGHTS RESERVED.

 NFPA Disclaimer Although Jonathan C. Willard is a principal member of the NFPA Technical Committee on Medical Gas and Vacuum Piping Systems, which is responsible for the applicable sections of NFPA 99: Health Care Facilities Code, and a principal member of the NFPA Technical Committee on Industrial and Medical Gases, responsible for NFPA 55: Compressed Gases and Cryogenic Fluids Code, the views and opinions expressed in this presentation are purely the authors and shall not be considered an official position of the NFPA or any of its Technical Committees and shall not be considered, nor be relied upon as, a Formal Interpretation or promotion of the NFPA. Readers are encouraged to refer to the entire text of all referenced documents for specific requirements. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 1: Administration Addition: This code shall apply to all health care facilities other than home care and veterinary care. Changes: Patient Care Spaces. “Rooms” changed to “Spaces” The governing body of the facility must designate the “Category” of each space. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 3: Definitions Change: Ambulatory Health Care Occupancy. Wording change makes this provision applicable to portions of the facility used for ambulatory health care. Change / New: Bulk Systems. Reorganized to better define systems. New definition to address requirements for “Micro-Bulk” systems. They are becoming very popular. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 3: Definitions Deletion: Nitrogen NF. Wording change to eliminate “oil-free, dry.” New: Nonmedical Compressed Air. Air that is used for purposes other than patient care or medical devices that provide direct patient care. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 3: Definitions New: Operating Pressure. The pressure that a particular piping system is set to operate at. Change: Working Pressure. Changed definition to “The maximum rated operating pressure.” 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 3: Definitions Change: Patient Care “Space.” Changed definition to better define “areas” within the facility. New: Qualified Person. A person who, by possession of a recognized degree, certificate, professional standing, or skill, and who, by knowledge, training, and experience, has demonstrated the ability to perform the work. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 3 & 4: Risk Assessments New: Risk Categories. Added “Activities” to Category definitions. Change: 4.1. Risk Categories. Patients, staff, and visitors replaces “staff and caregivers. Category 1 Designation, risk assessment is not required. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 4: Fundamentals New: Noncombustible Material. Requirements for compliance with this classification of materials. Limited-Combustible Material. Both are important for the design of medical gas system and cylinder storage locations. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Category 1 Summary. Category 1 piped gas or piped vacuum system requirements shall be applied where any of the following criteria is met: General anesthesia or deep sedation is performed. The loss of the system is likely to cause major injury or death to patients, staff, or visitors. The systems are intended for Category 1 Spaces. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Change / Moved: System Operations. New section for ongoing operations. Changed cylinder storage temperature to maximum of 125°F. Moved: System Operations. Moved all of the cylinder storage requirements to the operations section. This helps to apply the requirements to an existing facility. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New / Moved: System Locations. New section for new and existing locations. Indoor locations for oxygen, nitrous oxide, or mixtures of these gases shall not communicate with the following. Areas involved in critical patient care Anesthetizing locations Locations for storing flammables Rooms containing open electrical circuits Storage tanks for flammables or combustibles Engines, kitchens, or areas with open flames 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Change: (4). Design and Construction. Moved all of the cylinder storage requirements to the operations section. This helps to apply the requirements to an existing facility. (6). Design and Construction. Indoor locations for central supply systems and cylinder storage shall be in a room separated from the rest of the building by walls and floors having a one- hour fire rating with doors and other opening protections having a 3/4 hour fire protection rating. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: (14). Design and Construction. Added a reference for new construction to meet the operational requirements for room temperatures. New / Clarification: Ventilation. Ventilation for indoor locations used for medical gas storage or transfilling shall comply with the ventilation requirements in Chapter 9. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Auxiliary Source Connection. Added a requirement for an auxiliary source connection point to be installed for ALL source systems. The auxiliary connection shall be the same size as the main line and located immediately on the patient side of of the source valve. The connection shall consist of a tee, a service valve, and a removable plug or cap. This connection shall be normally closed and secured. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Auxiliary Source Connection. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Micro-Bulk and Small Bulk Cryogenic Systems. Added a new section to accommodate the increased use of small “micro-bulk” liquid oxygen systems at health care facilities. These can be located within the hospital…Not required to be installed outside. Requirements are a combination of those for a “standard” size bulk oxygen system and a liquid manifold system. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Micro-Bulk and Small Bulk Cryogenic Systems. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Change: Vacuum Exhaust. Changed back to the same materials that are allowed for the vacuum pipeline distribution systems and must be brazed. FYI…2012 changed to allow for any materials deemed suitable by the manufacturer. PVC started entering into the conversation!!! 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Clarification: Valves. Reorganized to be more clear. New: Valves. The valve section is less “prescriptive” in nature and more “performance” based. Allows for other than ball valves. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Clarification: Main Line Valves. Makes it clear that if there are multiple buildings served by a remote supply system, each building must have a main line valve. Manufactured Assemblies. Previous wording insinuated that station outlets and inlets were required in manufactured assemblies. Obviously, this isn’t the case. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Alarm Warning Systems. Requirement for a “means to indicate an audible failure.” How do we do this? Clarification: Master Alarms. Master alarm panels are required to “communicate” directly with the alarm initiating devices. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Wireless Master Alarm System. Mechanical Room Building #78 Mission Control 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Wireless Master Alarm System. Mission Control 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Piping Materials for Vacuum. Added specification to follow for stainless steel tubing and fittings. Clarification: Threaded Fittings. Limited to connections for pressure and vacuum indicators, alarm devices, gas-specific demand checks, and on the source side of the source valve. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Clarification: Prohibited Interconnections. Medical gas and vacuum systems with the same contents are permitted to be interconnected with an inline valve installed between the systems. New: Station Outlet and Inlet Labeling. In sleep labs, where the outlet is downstream of a flow control device, the station outlet identification shall include a warning not to use the outlet for ventilating patients. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

Sleep Lab Remote Control Panel
1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? 11/20/2018 COPYRIGHT © 2015, ALL RIGHTS RESERVED.

 Chapter 5: Gas and Vacuum Systems Reinforced: Alarm Panels. Labeling is more clearly defined. Now states labeling shall indicate for the condition monitored and the area of surveillance. Change: Odor Test. Added requirement for an odor test to be performed by the verifier. No pronounced or objectionable odor shall be discernable from any positive pressure outlet. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Operational Pressure Test. Added verification requirement to ensure outlets and inlets are labeled properly if the are operated at non-standard operating pressures, volume, or gas contents. Moved: Instrument Air Systems. Instrument air requirements have been moved to the Support Gas section of the document. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems Clarification / New: Qualifications. Reworded to state a “documented training program acceptable to the health care facility by which persons are employed or contracted to work with specific equipment as installed in that facility.” Still allowance for the following to qualify: ASSE 6030 Verifier Certification ASSE 6040 Maintenance Personnel Certification 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New: Information and Warning Signs. Labeling for shutoff valves and zone valves must now be kept up to date and modified to reflect any changes to the areas served. Information and Warning Signs. Labeling for area alarms panels must now be kept up to date and modified to reflect any changes to the areas served. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Chapter 5: Gas and Vacuum Systems New / Clarification / Change / All of the Above: Category 3 Medical Gas Systems. This section of the code has been rewritten again! Improvements have been made…But… Now applies to other than Dental! New: Filling Cylinder from O2 Concentrators. Allowance for this procedure, including in the patient care vicinity as long as it is completed in accordance with manufacturer’s instructions. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

NFPA 99: Health Care Facilities Code Medical Gas and Vacuum Systems
 NFPA 99: Health Care Facilities Code Medical Gas and Vacuum Systems NFPA 99, 2018 Update COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

The Joint Commission: Requirements for Medical Gas and Vacuum Systems
 The Joint Commission: Requirements for Medical Gas and Vacuum Systems Hospital Accreditation Standards – January, 2015. PRESENTED BY: Jonathan C. Willard, CPD, CMGV, LEED AP, CHC, PMP Acute Medical Gas Services, Inc. Manchester, New Hampshire COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Introduction The Medical Gases – CLASSIFIED Requirements to achieve and maintain compliance Applicable Elements of Performance – Including Regulatory Commentary Hazard Vulnerability Analysis and the Emergency Operations Plan Operation & Management Program COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 The Medical Gases - Classified Utility System? Systems that supports the environment of care. Life Support System? May apply to some medical gas systems Risk assessment to make determination. Hazardous Materials and Waste? Environmental Exposure Hazards (i.e. N2O, WAGD) Fire Risk? NFPA. Minimize Fire / Explosions. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 The Medical Gases - Classified Medical Device? Intended for use in treatment, diagnosis, or to affect the structure or function of the body. Recognized in the USP / NF Standards. High-Risk vs. Non-High-Risk Equipment? Risk assessment to make determination. Deemed Status for CMS Accreditation? 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 The Medical Gases - Classified Life Support Systems Discussion: Systems to consider: Oxygen and Medical Air Systems Do they serve critical care or anesthetizing locations? Vacuum Systems Does it serve critical care (i.e. chest tubes)? 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary High-Risk Designation: Systems and/or components that pose a risk of serious injury or death to a patient or personnel in the event of equipment or component failure. If, Life Supporting = High-Risk If not, risk assessment for determination. May still need to be on the inventory. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Requirements for Accreditation System Assessment and Classification High-Risk, Life Supporting, Deemed Status. Categorical Waiver (if applicable) on File Manage Risks in the Environment of Care Who’s Responsible? Written Plan to Manage the Systems EOP for Life Support / Critical Systems COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Medical Gas and Vacuum Systems EC : Inspects, Tests, & Maintains Critical components of piped systems including, but not limited to: Master and Area Alarm Signals Automatic Pressure Switches Shutoff Valves Flexible Connectors Tests systems for purity, correct gas, and proper pressure Initial Install, Modification, or Repair Main Supply and Area Shutoff Valves: Accessible Clearly Identified – Areas of Control COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Medical Gas and Vacuum Systems Regulatory Commentary Required Activities and Frequencies In time frames defined by the hospital, BUT: Annual Inspections Master and Area Alarms, Bulk Oxygen Supply Systems, Other Central Supply Systems Periodic Inspections Station Outlets and Inlets, Shutoff Valves, Articulating Booms and Assemblies (18 Mos.), Pressure Switches, and Flex Connectors Not to be confused with Best Practices or manufacturer’s recommendations. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Utility Systems EC : Manages Risks Written / Current Inventory Identifies Activities and Frequencies Manufacturer’s Recommendations AEM Program – Qualified Individual Procedures for Unplanned Disruptions System Shutdown, Personnel Notification, Clinical Interventions, Emergency Repairs, Restoration Controlling Airborne Contaminants (Gases) Ventilation, Exchange Rates, Waste Gas Disposal Maps Distribution of Systems Single-Line Drawings, Record Drawings 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary TJC Accreditation for Deemed Status: Written Inventory of all operating components of the utility systems. Activities and Frequencies must be in accordance with the manufacturer's recommendations if: Equipment is subject to federal or state law or Medicare Conditions for Participation. New operating components do not have sufficient history. AEM Program can be used, but it requires determination by a qualified individual. AEM items must be segregated on the written inventory. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Distribution System Mapping Single-Line drawings indicating: Inventory of systems and components Source equipment locations Pipeline distribution systems Emergency shutoff valve locations Alarm panel locations Accurate / Current Record Drawings COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Utility Systems EC : Inspects, Tests, & Maintains Tests system components before initial use and after major repairs or upgrades. Inspects, Tests, and Maintains High-Risk Utility Systems Infection Control Utility Systems Non-High-Risk Utility Systems Documentation Staff v. External Service Provider COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary If facility is performing its own inspections and/or maintenance: May verify competence. Permits professional qualifications to demonstrate competence. If outside vendor: Documentation may be offsite, as long as, it is available during survey. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Personnel Qualifications: Specific qualifications (i.e. ASSE Certifications) are not required. Technical competence and documented training are recommended. During a survey if the answers are In-house, In-house, In-house: Competence must be demonstrated. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Competence may be demonstrated by the following (NFPA 99, 2012 edition): ASSE 6040 Medical Gas Maintenance Personnel Certification ASSE 6010 Medical Gas Installer Certification ASSE 6030 Medical Gas Verifier Certification Documented training and certification through the hospital for specific equipment and/or activities being performed. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Hazardous Materials and Waste EC : Manages Risks Written / Current Inventory Those addressed by law and regulation Procedures for the response to exposures. Procedures for selecting, handling, storing, transporting, using, and disposing of hazardous gases, and vapors. Nitrous Oxide and Waste Anesthesia Gases Monitors levels of hazardous gases and vapors. Environmental Testing Program Proper labeling, hazard warnings, and safety data sheets available. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Safety and Security EC : Manages Risks Identifies risks and security sensitive areas Maintains grounds and equipment Controls access to security sensitive areas Locked and Labeled (NFPA / CGA) Written procedure for a security incident Responds to product notices and recalls Newer FDA requirement for product expiration dates. 1.) FDA Regulated Pharmaceutical Drugs, United Stated Pharmacopeia / National Formulary, Fire and Explosion Hazard, Environmental Exposure Hazard, 2.) TJC definition – 3.) It all depends on the treatments and uses…Questions to Ask: Do you have critical care patients on oxygen? Do you have patients with Chest Tubes? A, O, V are the easy ones? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Terrorism is a Real Threat! Security Sensitive Areas to Consider Bulk oxygen system and enclosure Medical gas manifold / storage rooms Medical gas mechanical rooms Emergency Oxygen Supply Connection Possible threats / risks include: System contamination; control valve shutoff; vehicular damage; fire/explosion COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Fire Safety EC : Manages Risks and Trains Written Fire Response Plan Describes specific roles and responsibilities of staff Procedures for the shutdown of life support systems Trains staff Roles and responsibilities Conducts fire drills COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Who authorizes the shutdown of the medical gas and/or vacuum systems? Who can shutdown the system with permission? Has training for staff been conducted for their roles and responsibilities? Consider signage on emergency valves. Simulate conditions with drills and/or training exercises. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Staff Competence EC : Roles and Responsibilities Staff shall be able to describe and demonstrate: Methods to eliminate and minimize physical risks in the EC Actions to take in the event of an EC incident How to report EC risks COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Monitor and Improve EC : Collect Information Established processes for continually monitoring, internally reporting, and investigating: Injuries and/or property damage Security incidents Hazardous materials and waste exposures Medical/Laboratory equipment problems, failures, and use errors Utility systems management problems, failures, and use errors Conducts annual tours; identifies deficiencies, hazards, and unsafe practices; and evaluates management plans. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Emergency Operations Plan EM : Planning Activities Hospital conducts a Hazard Vulnerability Analysis (HVA). Hospital uses HVA to define preparedness activities. Hospital keeps an inventory of all resources and assets to be used in an emergency. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary What systems will be needed in an emergency? How will you deal with a loss of that system during the emergency? Contingency Plans What resources and assets are required to meet these needs? These must be on an inventory. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Emergency Operations Plan EM : Response and recovery Response procedures for when an emergency event occurs Response procedure for when the hospital cannot be supported by the community 96 hours of operation requirement Recovery strategies and actions for restoring systems that are critical to providing care, treatment, and services after an emergency event. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Recovery Strategies Source equipment located in hospital basement… Equipment under water! Water in piping systems! How did we ensure systems were safe to return to service? No Road Map…Patient Safety was Priority. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Emergency Operations Plan EM : Resources and Assets How will hospital obtain and replenish medications during an emergency event? Supplier Agreement How will hospital share resources and assets during an emergency? Portable emergency supply systems How will hospital monitor quantities during emergency event? COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Contingency Planning Options Oxygen Systems Emergency Oxygen Supply Connection? HP Cylinder Back Feed System Inventory Required. Portable Emergency Oxygen Supply Manifold Hose Reel from Bulk System to EOSC COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Survey Findings and Experience: Regulatory Commentary Contingency Planning Options Vacuum Systems Portable Suction Units Crossover Piping with Other Vacuum Systems Memoranda of Understanding (MOU) Staff training for any contingency planning on roles and responsibilities. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Emergency Operations Plan EM & : Evaluates Plan The hospital conducts: An annual review of risks and hazards identified in the HVA An annual review of it’s inventory of required resources and assets to be used in an emergency The hospital conducts an emergency response exercise twice a year. Deficiencies and opportunities for improvement are identified and the EOP is modified to address these. COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

 Operation & Management Program Compliance Program Program Outline Risk Assessment Written Inventory of Systems and Critical Components Activities and Frequencies Policies and Procedures Personnel Qualifications MIT Documentation Emergency Operations / Contingency Planning COPYRIGHT © 2015, ALL RIGHTS RESERVED. 11/20/2018

COPYRIGHT © 2015, ALL RIGHTS RESERVED.

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COPYRIGHT © 2015, ALL RIGHTS RESERVED.

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